# FDA 483 - Pine Pharmaceuticals, LLC - May 14, 2021

Source: https://www.keypedia.com/records/483/pine-pharmaceuticals-llc/16873239-bd93-48e4-9478-be6263c251b0

> FDA 483 for Pine Pharmaceuticals, LLC on May 14, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pine Pharmaceuticals, LLC
- Inspection Date: 2021-05-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Pine Pharmaceuticals, LLC, an outsourcing facility in Tonawanda, NY, was inspected from 5/3/2021 to 5/14/2021. The inspection revealed significant deficiencies in quality control, including failures to thoroughly investigate out-of-specification results, inadequate procedures to prevent microbiological contamination of sterile products, and release of products based on unvalidated test methods. Additionally, the firm lacked proper laboratory controls and maintenance records for equipment calibration.

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## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Johnna L. Bleem](https://www.keypedia.com/people/johnna-l-bleem/3fe669bf-e354-4cdc-9337-d5ceb23f1c9f)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961