483
TriRx Huntsville Pharmaceutical Services, LLCTriRx Huntsville Pharmaceutical Services, LLC – FDA 483, Dec 19, 2014
Record Details
An FDA inspection of Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals in Huntsville, AL, identified a significant quality control deficiency. The firm failed to reject finished drug product batches that did not meet established in-process specifications. Additionally, reprocessing of these non-conforming batches was not performed, indicating a serious lapse in product quality assurance.
- Inspection date
- December 19, 2014
- Product type
- drugs
- Person
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ID · fcff31f5-6239-4b24-b66b-0b23a743cdd5
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