# FDA 483 - Packaging Coordinators, LLC - January 31, 2025

Source: https://www.globalkeysolutions.net/records/483/packaging-coordinators-llc/90bdaadc-f894-4478-bd7f-ce4f46c7e033

> FDA 483 for Packaging Coordinators, LLC on January 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Packaging Coordinators, LLC
- Inspection Date: 2025-01-31
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Packaging Coordinators, LLC in Philadelphia, PA, was issued a Form 483 following an inspection from January 27-31, 2025, citing significant deficiencies in its quality control unit. The firm failed to adhere to written procedures for managing quarantined and rejected materials, reviewing production and temperature records, initiating deviations promptly, and maintaining consistent cleaning schedules. These findings indicate a serious lack of oversight and compliance within the quality system.

## Related Documents

- [EIR - 2020-12-18](https://www.globalkeysolutions.net/records/eir/packaging-coordinators-llc/f46de4ad-f56e-4378-9591-86cb4d3c10ad)
- [EIR - 2022-10-21](https://www.globalkeysolutions.net/records/eir/packaging-coordinators-llc/9e2c6978-4db6-4e7a-9952-da7fda5baf16)
- [483 - 2022-10-21](https://www.globalkeysolutions.net/records/483/packaging-coordinators-llc/916c5517-aa74-4b96-9fec-b9748ba77155)
- [483 - 2023-01-12](https://www.globalkeysolutions.net/records/483/packaging-coordinators-llc/41a0b689-1344-46a7-a23e-e99f20c99184)

## Related Officers

- [Auburn Su](https://www.globalkeysolutions.net/people/auburn-su/2e56b2fe-9da4-4544-92b0-a1b5f6da9c4c)
- [Ruben C. Quintana](https://www.globalkeysolutions.net/people/ruben-c-quintana/fbf0f0ef-eb51-4a06-a4b9-f7856fa06c58)
- [Yaharn Su](https://www.globalkeysolutions.net/people/yaharn-su/75b7f7fd-d853-436e-b538-386a8c6df3cb)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [Evan Tong](https://www.globalkeysolutions.net/people/evan-tong/2cd81562-886c-4672-9522-a07fb1b33ef2)

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

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8