483
Boehringer Ingelheim Animal Health Puerto Rico LLCBoehringer Ingelheim Animal Health Puerto Rico LLC – FDA 483, Mar 29, 2019
Record Details
An FDA inspection of Boehringer Ingelheim Animal Health Puerto Rico LLC in Barceloneta, PR, revealed a significant failure to thoroughly review unexplained discrepancies. The firm did not adequately investigate out-of-specification environmental monitoring events or take sufficient action to mitigate recurring issues in a high-risk manufacturing area. This indicates deficiencies in their quality operations and investigation processes.
- Inspection date
- March 29, 2019
- Product type
- drugs
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ID · e7c75bb9-7697-4b58-98bd-2383b57280ca
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