# FDA 483 - Packaging Coordinators, LLC - January 12, 2023

Source: https://www.keypedia.com/records/483/packaging-coordinators-llc/41a0b689-1344-46a7-a23e-e99f20c99184

> FDA 483 for Packaging Coordinators, LLC on January 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Packaging Coordinators, LLC
- Inspection Date: 2023-01-12
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Packaging Coordinators, LLC in Philadelphia, PA, a drug labeler and packager, revealed significant deficiencies across multiple areas. The firm failed to establish adequate production and process controls, maintain appropriate equipment design, and ensure proper quality control unit procedures. Additionally, buildings and equipment were not kept in a clean and sanitary condition, indicating a broad lack of GMP compliance.

## Related Documents

- [EIR - 2020-12-18](https://www.keypedia.com/records/eir/packaging-coordinators-llc/f46de4ad-f56e-4378-9591-86cb4d3c10ad)
- [EIR - 2022-10-21](https://www.keypedia.com/records/eir/packaging-coordinators-llc/9e2c6978-4db6-4e7a-9952-da7fda5baf16)
- [483 - 2022-10-21](https://www.keypedia.com/records/483/packaging-coordinators-llc/916c5517-aa74-4b96-9fec-b9748ba77155)
- [483 - 2025-01-31](https://www.keypedia.com/records/483/packaging-coordinators-llc/90bdaadc-f894-4478-bd7f-ce4f46c7e033)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/packaging-coordinators-llc/a9f0569b-fa13-4898-ae16-74ed60a0e3be

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd