# FDA 483 - Pine Pharmaceuticals, LLC - September 30, 2024

Source: https://www.globalkeysolutions.net/records/483/pine-pharmaceuticals-llc/61efa7fb-c465-4751-8312-aee5e5755f10

> FDA 483 for Pine Pharmaceuticals, LLC on September 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pine Pharmaceuticals, LLC
- Inspection Date: 2024-09-30
- Product Type: drugs
- Office Name: New York District Office
- Summary: Pine Pharmaceuticals, LLC in Tonawanda, NY, an outsourcing facility, was cited for significant deficiencies across its aseptic processing, environmental monitoring, and quality control systems during an inspection from August 5 to September 30, 2024. The firm failed to maintain adequate air quality, prevent microbiological contamination, and thoroughly investigate batch failures and product quality issues, including repeated observations from a previous inspection. These lapses led to the release of drug products with potential quality defects and a lack of robust process controls.

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## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.globalkeysolutions.net/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)
- [Jazmine N. Brown](https://www.globalkeysolutions.net/people/jazmine-n-brown/194fc53f-942f-4e8c-a475-b7eac11be103)
- [Lauren H. Augustyniak](https://www.globalkeysolutions.net/people/lauren-h-augustyniak/bde81fac-921f-494b-969b-38770fceda7e)
- [National Expert, Pharmaceutical](https://www.globalkeysolutions.net/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)
- [Jasmine B. Brown](https://www.globalkeysolutions.net/people/jasmine-b-brown/12c89e6f-a6a5-4fb7-8c38-a75596191e28)

Company: https://www.globalkeysolutions.net/companies/pine-pharmaceuticals-llc/03870efc-b074-462a-8520-e5cadc945149

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d