PL Developments LLC
Packager Re-Packager OTC Solid Dose products
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TOPCARE HEALTH DIPHENHYDRAMINE HCL 50MG SOFTGEL 32CT
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WALGREENS MINOXIDIL 2% TOPICAL LIQUID 2 OZ
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MINOXIDIL 2% WOMENS TOPICAL LIQUID
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WALGREENS MINOXIDIL 5% TOPICAL LIQUID 2 + 2 + 2 (2 OZ)
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NICOTINE 2MG FRUIT-COATED USP GUM
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WALGREENS NICOTINE 2MG MINT MINI LOZENGE 20CT
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WALGREENS DAYTIME PE LIQUID 8 OZ
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WALGREENS NIGHTTIME COLD & FLU ORIGINAL LIQUID 8 OZ
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WALGREENS NIGHTTIME COLD & FLU CHERRY LIQUID 8 OZ
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WALGREENS MICONAZOLE 2% CREAM AND MICONAZOLE 200MG SUPPOSITORY 0.32 OZ + 3CT & 3 APPLICATORS
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NICOTINE 4MG FRUIT-COATED USP GUM
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WALGREENS DAYTIME SEVERE COLD & FLU LIQUID 8 OZ
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WALGREENS ESOMEPRAZOLE DELAYED RELEASED 20MG TABLET 42CT
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WALGREENS MINOXIDIL 5% TOPICAL LIQUID 2 OZ
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WALGREENS NICOTINE 4MG MINT MINI LOZENGE 20CT
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PEPTIC RELIEF CHERRY NO VEEGUM LIQUID
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WINCO EPSOM SALT EUCALYPTS 3 LB
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Locations
| Location name | Address |
|---|---|
| PATHEON SOFTGELS INC (Banner Pharmacaps) - High Point, NC | 4125 Premier Dr High Point, NC 27265 USA |
| PL Developments | 26 Bethpage Rd, Copiague, NY 11726 USA |
| PL Developments - Accucaps - Strathroy | 720 Wright Street Strathroy, ON N7G 3H8 CAN |
| PL Developments - Clinton, SC | 1874 Highway 72 West Clinton, SC 29325 USA |
| PL Developments - Lynwood, CA | 11865 S. Alameda St. Lynwood, CA 90262 USA |
| PL Developments - Piedmont, SC (OGR) | 13 Old Griffin Road Piedmont, SC 29673 USA |
| PL Developments - TrueCare Biomedix | RS/2115, College Road Balasinor, GJ 388255 IND |
| PL Developments (Actavis / Teva) - Davie, FL | 4955 Orange Drive 4955 Orange Drive Davie, FL 33314 USA |
| PL Developments (ADMI/PLD) - Miami, FL | 10400 NW 29th Terrace Miami, FL 33172 USA |
| PL Developments (Amneal Pharmaceuticals) - Brookhaven, NY 11719 | 50 Horseblock Rd Brookhaven, NY 11719 USA |
| PL Developments (Encube Ethicals Pvt.) - Madkaim, Pongoa, India | Plot No C-1, Madkaim Industrial Estate Ponda, Goa 403404 IND |
| PL Developments (Giles Chemical LLC) - Waynesville, NC | 102 Commerce Street Waynesville, NC 28786 USA |
| PL Developments (Glenmark Pharmaceuticals USA) - Covale, Goa, India | Plot No S7, Colvale Industrial Estate Colvale, GA 403513 IND |
| PL Developments (Humanwell Puracap) - Wuhan, Hubei, China | No.99, 2nd Shendun Road, East Lake New Technology Development District Wuhan, HB 430206 CHN |
| PL Developments- Accucaps - Windsor | 2125 Ambassador Drive Windsor, ON N9C 3R5 CAN |
| PL Developments LLC -Westbury | 609-2 Cantiague Rock Road 200 Hicks Street Westbury, New York 11590 USA |
Documents
| Type | Location | File name | Effective | Expiration |
|---|---|---|---|---|
| 3rd Party Audit Certificate | PL Developments LLC -Westbury | 00002346 - PL Developments, LLC - Westbury, NY - OTC Certificate - 2.17.2025.pdf | 2/17/2025 | 6/13/2028 |
| 3rd Party Audit Report | PL Developments LLC -Westbury | 00002346 - PL Developments, LLC - Westbury, NY - OTC Result Report (Audit-Inspection report) - 2.17.2025.pdf | 2/17/2025 | 3/2/2026 |
| 3rd Party Audit Certificate | PL Developments - TrueCare Biomedix | 2020 TrueCare Biomedix 393655 CofC Issue 6 (1).pdf | 3/23/2021 | 3/21/2023 |
| GFSI Certificate | PL Developments LLC -Westbury | 2021 PL Developments, LLC 442238 CofC Issue8 (3).pdf | 11/20/2023 | 11/19/2024 |
| 3rd Party Audit Certificate | PL Developments (Humanwell Puracap) - Wuhan, Hubei, China | 2022 Humanwell PuraCap Pharmaceuticals (Wuhan) Co. Ltd 571026 Final Assessment Report.pdf | 1/12/2023 | 1/12/2024 |
| 3rd Party Audit Certificate | PATHEON SOFTGELS INC (Banner Pharmacaps) - High Point, NC | 2022 Patheon Softgels Inc. 643523 Final Assessment Results.pdf | 1/12/2023 | 1/12/2024 |
| 3rd Party Audit Certificate | PL Developments - Piedmont, SC (OGR) | 2022 PL Developments - OGR 639116 CofC Issue 5.pdf | 8/2/2022 | 9/3/2025 |
| GFSI Audit Report | PL Developments LLC -Westbury | 2022 PL Developments, LLC 714496 Final Assessment Results (Westbury).pdf | 11/20/2023 | 11/19/2024 |
| 3rd Party Audit Certificate | PL Developments (ADMI/PLD) - Miami, FL | 2022 PLD Acquisition, LLC DBA Avema Pharma Solutions 699204 Final Assessment Report.pdf | 1/12/2023 | 1/12/2024 |
| 3rd Party Audit Certificate | PL Developments (Encube Ethicals Pvt.) - Madkaim, Pongoa, India | 2023 Encube Ethicals Pvt. Ltd. 851271 CofC Issue 4 (1).pdf | 5/26/2023 | 2/1/2024 |
| 3rd Party Audit Report | PL Developments (ADMI/PLD) - Miami, FL | 2023 PLD Acquisition, LLC DBA Avema Pharma Solutions 839535 Final Assessment Results (1).pdf | 11/28/2022 | 11/19/2025 |
| 3rd Party Audit Certificate | PL Developments - Clinton, SC | 2024 - PL Developments LLC - 994166 - OTC CofC Issue 9 (1).pdf | 2/19/2025 | 6/10/2025 |
| 3rd Party Audit Report | PL Developments - Piedmont, SC (OGR) | 2024 - PL Developments LLC - 994166a - OTC Final Report.pdf | 4/22/2024 | 6/6/2025 |
| 3rd Party Audit Report | PL Developments - TrueCare Biomedix | 2024 - TrueCare Biomedix - 1005076 - Final Report.pdf | 5/21/2024 | 6/6/2025 |
| 3rd Party Audit Certificate | PL Developments (Amneal Pharmaceuticals) - Brookhaven, NY 11719 | 2024 Amneal Pharmaceuticals 925981 CofC Issue 12.pdf | 4/11/2024 | 4/11/2025 |
| 3rd Party Audit Report | PL Developments (Amneal Pharmaceuticals) - Brookhaven, NY 11719 | 2024 Amneal Pharmaceuticals 925981 Final Assessment Results.pdf | 4/11/2024 | 4/11/2025 |
| 3rd Party Audit Certificate | PL Developments- Accucaps - Windsor | 2024 Catalent Ontario Limited 934557 CofC Issue 8 (OTC).pdf | 3/20/2024 | 8/30/2027 |
| 3rd Party Audit Certificate | PL Developments - Accucaps - Strathroy | 2024 Catalent Ontario Limited 934557 CofC Issue 8 (OTC).pdf | 3/20/2024 | 8/30/2027 |
| 3rd Party Audit Report | PL Developments- Accucaps - Windsor | 2024 Catalent Ontario Limited 934557 Final Assessment Results (OTC) Redacted_Redacted.pdf | 6/7/2024 | 6/6/2025 |
| 3rd Party Audit Report | PL Developments - Accucaps - Strathroy | 2024 Catalent Ontario Limited 934557 Final Assessment Results (OTC) Redacted_Redacted.pdf | 6/7/2024 | 6/6/2025 |
| 3rd Party Audit Report | PL Developments (Giles Chemical LLC) - Waynesville, NC | 2024 Giles Chemical Corporation, a division of Premier Magnesia, LLC 994759 Final Assessment Results.pdf | 7/1/2024 | 7/1/2025 |
| 3rd Party Audit Certificate | PL Developments (Glenmark Pharmaceuticals USA) - Covale, Goa, India | 2024 Glenmark Pharmaceuticals Limited, Goa 1062404 CofC Issue 7.pdf | 7/30/2024 | 9/4/2025 |
| 3rd Party Audit Report | PL Developments (Glenmark Pharmaceuticals USA) - Covale, Goa, India | 2024 Glenmark Pharmaceuticals Limited, Goa 972760 Final Assessment Results.pdf | 4/24/2024 | 6/6/2025 |
| Social Compliance Audit | PL Developments (Humanwell Puracap) - Wuhan, Hubei, China | 2024 Humanwell PuraCap Pharmaceuticals (Wuhan) Co. Ltd. 1070243 Final Report.pdf | 3/19/2025 | 3/19/2026 |
| 3rd Party Audit Corrective Action Plan | PL Developments (Humanwell Puracap) - Wuhan, Hubei, China | 2024 Humanwell PuraCap Pharmaceuticals (Wuhan) Co. Ltd. 1070243 Final Report.pdf | 3/19/2025 | 3/20/2025 |
| 3rd Party Audit Report | PL Developments (Humanwell Puracap) - Wuhan, Hubei, China | 2024 Humanwell PuraCap Pharmaceuticals (Wuhan) Co. Ltd. 1070243 Final Report.pdf | 3/19/2025 | 3/20/2025 |
| 3rd Party Audit Report | PL Developments | 2024 Humanwell PuraCap Pharmaceuticals (Wuhan) Co. Ltd. 1070243 Final Report.pdf | 10/9/2024 | 10/31/2024 |
| 3rd Party Audit Report | PATHEON SOFTGELS INC (Banner Pharmacaps) - High Point, NC | 2024 Patheon UL Audit Report.pdf | 1/15/2025 | 2/15/2026 |
| 3rd Party Audit Certificate | PL Developments - Lynwood, CA | 2024 PL Developments LLC Lynwood 1095249 OTC CofC Issue 11.pdf | 12/11/2024 | 11/28/2027 |
| 3rd Party Audit Report | PL Developments - Lynwood, CA | 2024 PL Developments LLC Lynwood 1095249 OTC Final Report.pdf | 12/11/2024 | 12/25/2025 |
| 3rd Party Audit Report | PL Developments (Swiss Caps Romania) - Prahova, Romania | 2024 S.C. SWISSCAPS Romania S.R.L. 948476 Final Assessment Results (OTC).pdf | 3/6/2024 | 9/1/2025 |
| Quarterly Adverse Event Report | PL Developments (Amneal Pharmaceuticals) - Brookhaven, NY 11719 | Amneal Q4 2024.pdf | 2/20/2025 | 5/21/2025 |
| Contact Information | PL Developments (Amneal Pharmaceuticals) - Brookhaven, NY 11719 | Amneal-Brookhaven Contact Info (11-13-2024).docx | 11/13/2024 | 11/13/2025 |
| Contact Information | PL Developments (ADMI/PLD) - Miami, FL | Avema Pharma-PLD Miami Contact Info (11-13-2024).docx | 11/13/2024 | 11/13/2025 |
| Quarterly Adverse Event Report | PL Developments- Accucaps - Windsor | Catalent Q4 2024.pdf | 2/20/2025 | 5/21/2025 |
| Quarterly Adverse Event Report | PL Developments - Accucaps - Strathroy | Catalent Q4 2024.pdf | 2/20/2025 | 5/21/2025 |
| Contact Information | PL Developments - Accucaps - Strathroy | Catalent-Strathroy Contact Info (11-13-2024).docx | 11/13/2024 | 11/13/2025 |
| Contact Information | PL Developments- Accucaps - Windsor | Catalent-Windsor Contact Info (11-13-2024).docx | 11/13/2024 | 11/13/2025 |
| Recall/Emergency/Contact List | PL Developments (Encube Ethicals Pvt.) - Madkaim, Pongoa, India | Contact Info-25 octuber 2023 (Encube).docx | 10/25/2023 | 10/24/2024 |
| Contact Information | PL Developments - TrueCare Biomedix | Contact Information - TrueCare Biomedix.docx | 12/2/2024 | 12/2/2025 |
| Contact Information | PL Developments LLC -Westbury | ContactInfo-28Sept21 (2).docx | 12/10/2024 | 12/10/2025 |
| Quality Manual | PL Developments LLC -Westbury | D001545 - Quality Manual Rev. 5.pdf | 11/17/2023 | 11/16/2026 |
| FDA Registration | PL Developments LLC -Westbury | Drug Establishments Current Registration Site.pdf | 12/26/2023 | 12/31/2025 |
| Copies of FDA Establishment Inspection Reports, Form 483s and/or warning letters received | PL Developments LLC -Westbury | EIR PLD NY_Redacted (PL Developments Westbury, NY).pdf | 11/16/2023 | 11/15/2026 |
| Contact Information | PL Developments (Encube Ethicals Pvt.) - Madkaim, Pongoa, India | Encube Contact Info (11-13-2024).docx | 11/13/2024 | 11/13/2025 |
| Quarterly Adverse Event Report | PL Developments (Encube Ethicals Pvt.) - Madkaim, Pongoa, India | Encube Q4 2024.pdf | 2/20/2025 | 5/21/2025 |
| Environmental Monitoring SOP | PL Developments LLC -Westbury | Environmental Monitoring SOP.pdf | 11/16/2023 | 11/15/2026 |
| Environmental Policy | PL Developments LLC -Westbury | Environmental Policy Statement.pdf | 11/20/2023 | 11/19/2024 |
| FDA Registration | PL Developments | FDA Registrations.docx | 1/13/2025 | 1/14/2025 |
| Contact Information | PL Developments (Giles Chemical LLC) - Waynesville, NC | Giles Chemical Contact Info (11-13-2024).docx | 11/13/2024 | 11/13/2025 |
| Quarterly Adverse Event Report | PL Developments (Giles Chemical LLC) - Waynesville, NC | Giles Q4 2024.pdf | 2/20/2025 | 5/21/2025 |
| Contact Information | PL Developments (Glenmark Pharmaceuticals USA) - Covale, Goa, India | Glenmark Contact Info (11-13-2024).docx | 11/13/2024 | 11/13/2025 |
| FDA Registration | PL Developments (Humanwell Puracap) - Wuhan, Hubei, China | Humanwell PuraCap Pharmaceuticals (Wuhan) Co Ltd_FDA Registration 03192025.docx | 3/19/2025 | 3/20/2025 |
| Bioterrorism Letter | PL Developments LLC -Westbury | NotApplicable_BioterrorismLetter.pdf | 11/16/2023 | 11/15/2024 |
| Example MMR Template | PL Developments LLC -Westbury | NotApplicable_ExampleMMRTemplate.pdf | 11/17/2023 | 11/16/2026 |
| Food Defense Plan Statement | PL Developments LLC -Westbury | NotApplicable_FoodDefensePlanStatement.pdf | 11/17/2023 | 11/16/2025 |
| GFSI Corrective Action | PL Developments LLC -Westbury | NotApplicable_GFSICorrectiveAction.pdf | 1/31/2025 | 1/31/2026 |
| HACCP Plan (Facility) | PL Developments LLC -Westbury | NotApplicable_HACCPPlanFacility.pdf | 11/17/2023 | 11/16/2025 |
| HARPC Food Safety Plan (Facility) | PL Developments LLC -Westbury | NotApplicable_HARPCFoodSafetyPlanFacility.pdf | 11/17/2023 | 11/16/2026 |
| Organic Facility Cert | PL Developments LLC -Westbury | NotApplicable_OrganicFacilityCert.pdf | 11/17/2023 | 11/16/2024 |
| Quarterly Adverse Event Report | PL Developments (Glenmark Pharmaceuticals USA) - Covale, Goa, India | NotApplicable_QuarterlyAdverseEventReport.pdf | 2/20/2025 | 5/21/2025 |
| Quarterly Adverse Event Report | PL Developments - Clinton, SC | NotApplicable_QuarterlyAdverseEventReport.pdf | 2/20/2025 | 5/21/2025 |
| Quarterly Adverse Event Report | PL Developments LLC -Westbury | NotApplicable_QuarterlyAdverseEventReport.pdf | 2/20/2025 | 5/21/2025 |
| Quarterly Adverse Event Report | PL Developments (Swiss Caps Romania) - Prahova, Romania | NotApplicable_QuarterlyAdverseEventReport.pdf | 2/20/2025 | 5/21/2025 |
| Recall/Emergency/Contact List | PL Developments (Amneal Pharmaceuticals) - Brookhaven, NY 11719 | NotApplicable_RecallEmergencyContactList.pdf | 11/16/2023 | 11/15/2024 |
| Own Brand Supplier Quality and Compliance Requirements | PL Developments LLC -Westbury | Own Brand Supplier Quality and Compliance Requirements v.13.pdf | 1/31/2025 | 1/31/2027 |
| Contact Information | PATHEON SOFTGELS INC (Banner Pharmacaps) - High Point, NC | Patheon Contact List (11-13-2024).docx | 11/13/2024 | 11/13/2025 |
| Quarterly Adverse Event Report | PATHEON SOFTGELS INC (Banner Pharmacaps) - High Point, NC | Patheon Q4 2024.pdf | 2/20/2025 | 5/21/2025 |
| Pathogen Monitoring Program | PL Developments LLC -Westbury | Pathogen Monitoring Program_PLD.pdf | 2/21/2025 | 2/21/2026 |
| Contact Information | PL Developments - Clinton, SC | PLD Clinton Contact Info (11-13-2024).docx | 11/13/2024 | 11/13/2025 |
| 3rd Party Audit Report | PL Developments - Clinton, SC | PLD Clinton Memo.pdf | 4/8/2025 | 4/8/2030 |
| Contact Information | PL Developments - Lynwood, CA | PLD Lynwood Contact Info (11-13-2024).docx | 11/13/2024 | 11/13/2025 |
| Quarterly Adverse Event Report | PL Developments - Lynwood, CA | PLD Lynwood Q4 2024.pdf | 2/20/2025 | 5/21/2025 |
| Quarterly Adverse Event Report | PL Developments (ADMI/PLD) - Miami, FL | PLD Miami Q4 2024.pdf | 2/20/2025 | 5/21/2025 |
| Recall/Emergency/Contact List | PL Developments - Piedmont, SC (OGR) | PLD OGR Recall Emergency Contact List - Effective 01-02-2024.pdf | 12/30/2024 | 12/30/2025 |
| Recall/Emergency/Contact List | PL Developments LLC -Westbury | PLD Recall Emergency Contact List- Effective December 2022.pdf | 12/30/2024 | 12/30/2025 |
| Quarterly Adverse Event Report | PL Developments (Humanwell Puracap) - Wuhan, Hubei, China | Puracap Q4 2024.pdf | 2/20/2025 | 5/21/2025 |
| Recall/Emergency/Contact List | PL Developments - Accucaps - Strathroy | Recall Emergency Contact List (Westbury).pdf | 11/13/2024 | 11/13/2025 |
| Recall/Emergency/Contact List | PL Developments (Humanwell Puracap) - Wuhan, Hubei, China | Recall Emergency Contact List (Westbury).pdf | 11/13/2024 | 11/13/2025 |
| Recall/Emergency/Contact List | PL Developments - TrueCare Biomedix | Recall Emergency Contact List (Westbury).pdf | 11/13/2024 | 11/13/2025 |
| Recall/Emergency/Contact List | PL Developments- Accucaps - Windsor | Recall Emergency Contact List 2023.pdf | 1/12/2023 | 1/12/2024 |
| Recall/Emergency/Contact List | PATHEON SOFTGELS INC (Banner Pharmacaps) - High Point, NC | Recall Emergency Contact List.pdf | 8/1/2022 | 8/1/2023 |
| Recall/Emergency/Contact List | PL Developments (ADMI/PLD) - Miami, FL | Recall Emergency Contact List.pdf | 8/1/2022 | 8/1/2023 |
| Recall/Emergency/Contact List | PL Developments (Actavis / Teva) - Davie, FL | Recall Emergency Contact List.pdf | 8/1/2022 | 8/1/2023 |
| Recall/Emergency/Contact List | PL Developments (Giles Chemical LLC) - Waynesville, NC | Recall Emergency Contact List.pdf | 2/23/2022 | 2/23/2023 |
| Recall/Emergency/Contact List | PL Developments (Swiss Caps Romania) - Prahova, Romania | Recall Emergency Contact List.pdf | 2/23/2022 | 2/23/2023 |
| Recall Plan | PL Developments - Clinton, SC | Recall Emergency Contact Listpdf PLD Clinton Effective December 2022.pdf | 6/17/2024 | 6/17/2025 |
| Recall/Emergency/Contact List | PL Developments - Clinton, SC | Recall Emergency Contact Listpdf PLD Clinton Effective December 2022.pdf | 12/30/2024 | 12/30/2025 |
| Recall/Emergency/Contact List | PL Developments - Lynwood, CA | Recall Emergency Contact Listpdf PLD Lynwood Effective December 2022.pdf | 3/31/2025 | 3/31/2026 |
| 3rd Party Audit Certificate | PL Developments (Swiss Caps Romania) - Prahova, Romania | S.C. SWISSCAPS Romania S.R.L. 546541 CofC Issue 6_2022_OTC.pdf | 4/11/2022 | 5/1/2023 |
| SOP Index | PL Developments LLC -Westbury | SOP Index.xlsx | 11/17/2023 | 11/16/2026 |
| Recall Plan | PL Developments - Piedmont, SC (OGR) | SOP000224 Product Recalls and Withdrawals Rev. 10 (CONF).pdf | 3/13/2025 | 3/13/2026 |
| Recall Plan | PL Developments LLC -Westbury | SOP000224 Product Recalls and Withdrawals Rev. 10 (CONF).pdf | 3/13/2025 | 3/13/2026 |
| Recall Plan | PL Developments - Lynwood, CA | SOP000224 Product Recalls and Withdrawals Rev. 9.pdf | 3/31/2025 | 3/31/2026 |
| Allergen Control Policy | PL Developments LLC -Westbury | SOP001646 Allergen Management Guidance Rev. 1 (2).pdf | 11/16/2023 | 11/15/2025 |
| Supplier Questionnaire | PL Developments - Lynwood, CA | Supplier Questionnaire.pdf | 4/24/2024 | 4/24/2026 |
| Supplier Questionnaire | PL Developments - Clinton, SC | Supplier Questionnaire.pdf | 4/11/2024 | 4/11/2026 |
| Supplier Questionnaire | PL Developments LLC -Westbury | Supplier Questionnaire.pdf | 3/26/2024 | 3/26/2026 |
| Supplier Questionnaire | PL Developments - Piedmont, SC (OGR) | Supplier Questionnaire.pdf | 4/1/2024 | 4/1/2026 |
| Contact Information | PL Developments (Swiss Caps Romania) - Prahova, Romania | Swiss Caps Romania Contact Info (11-13-2024).docx | 11/13/2024 | 11/13/2025 |
| Contact Information | PL Developments (Humanwell Puracap) - Wuhan, Hubei, China | TopCo Contact Information PuraCap - 3-2025.docx | 3/14/2025 | 3/14/2026 |
| Quarterly Adverse Event Report | PL Developments - TrueCare Biomedix | TrueCare Biomedix Q4 2024.pdf | 2/20/2025 | 5/21/2025 |