# FDA 483 - Pine Pharmaceuticals, LLC - September 19, 2023

Source: https://www.keypedia.com/records/483/pine-pharmaceuticals-llc/3c7b832f-d00c-40e1-9678-fd3f0822759f

> FDA 483 for Pine Pharmaceuticals, LLC on September 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pine Pharmaceuticals, LLC
- Inspection Date: 2023-09-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Pine Pharmaceuticals, LLC in Tonawanda, NY, from September 6-19, 2023, revealed significant deficiencies across multiple areas. The firm's quality control unit lacked proper authority and failed to adequately investigate product defects, batch failures, and complaints, including those related to particulate matter. Additionally, the inspection identified issues with aseptic processing, environmental control, facility cleanliness, and a failure to report compounded drugs to the FDA.

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## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)

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