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

Source: https://www.keypedia.com/records/483/packaging-coordinators-llc/2d592fc5-1166-4fef-9db8-afbc97735e7e

> 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: Baltimore District Office
- Summary: An FDA inspection conducted from January 9-12, 2023, identified significant deficiencies at Packaging Coordinators, LLC, a drug labeler and packager in Philadelphia, PA. The observations, documented in a Form FDA 483, primarily relate to non-compliance with Current Good Manufacturing Practices (GMP). Key issues include inadequate written procedures for production and process controls. Specifically, the firm's environmental monitoring plan was insufficient for syringe assembly and blistering lines, lacking surface monitoring for product contact areas. There was no procedural requirement to confirm the absence of moisture or other defects in blister packaging post-sealing, despite customer complaints. The validation for the sterilization process, crucial for maintaining sterile barriers, was not verified under worst-case conditions. Furthermore, the product assessment for bioburden control was deficient, omitting face masks from standard gowning, and production rooms lacked adequate air pressure control. The requalification of the sterilization process used non-representative loads. The inspection also noted equipment design flaws, such as an "oil-free" air compression system for sterilization that was not actually oil-free and included cast iron piping. The quality control unit failed to follow its own procedures, leading to the release of drug products with incorrect lot numbers and expiration dates. This included a repeat observation regarding the inadequate effectiveness checks for Corrective and Preventive Actions (CAPAs). Lastly, significant concerns were raised about facility and equipment sanitation, with observations of deteriorated insulation, excess grease, dirty air compressors, waste material in a finished product refrigerator, and a non-functioning automated door. Packaging Coordinators, LLC is required to promptly address these serious observations to ensure product quality and regulatory compliance.

## Related Documents

- [EIR - 2017-09-06](https://www.keypedia.com/records/eir/packaging-coordinators-llc/cf0384f1-a758-4a28-8bab-41c5e89a9158)
- [EIR - 2020-12-18](https://www.keypedia.com/records/eir/packaging-coordinators-llc/f46de4ad-f56e-4378-9591-86cb4d3c10ad)
- [483 - 2022-10-21](https://www.keypedia.com/records/483/packaging-coordinators-llc/916c5517-aa74-4b96-9fec-b9748ba77155)
- [EIR - 2022-10-21](https://www.keypedia.com/records/eir/packaging-coordinators-llc/9e2c6978-4db6-4e7a-9952-da7fda5baf16)
- [483 - 2023-01-12](https://www.keypedia.com/records/483/packaging-coordinators-llc/41a0b689-1344-46a7-a23e-e99f20c99184)

## Related Officers

- [Shane Shupe, Senior Manager, Regulatory Affairs](https://www.keypedia.com/people/shane-shupe-senior-manager-regulatory-affairs/1a2bfe83-f45c-4a6d-9de4-48c6a0f4fe36)
- [Ben Du](https://www.keypedia.com/people/ben-du/2bd46e1e-9e53-499f-be77-f006b789bb98)
- [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)
- [Regulatory Counsel](https://www.keypedia.com/people/brandy-edmonds/4deaf964-71fc-4406-8eb9-480c79bbcd2e)

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa