> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Pine Pharmaceuticals FDA-483 Released
- URL: https://www.fdaweb.com/pine-pharmaceuticals-fda-483-released/
- Published: 2018-05-24T12:00:00.000Z
- Updated: 2026-09-15T00:07:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141534

FDA has released the FDA-483 issued following a 4/11-4/26 inspection at Pine Pharmaceuticals, a Tonawanda, NY, outsourcing facility. The three observations listed on the [form](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm608546.pdf?ref=fdaweb.com) were: 

- employees engaged in the processing of a drug product lack the training required to perform their assigned functions;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed; and
- strict control is not exercised over labeling issued for use in drug product labeling operations.