483
Integris Bioservices LLCFDA 483 - Integris Bioservices LLC
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Record Details
KCAS Bioanalytical Services, a Contract Research Organization in Shawnee, Kansas, was inspected by the FDA from June 20-24, 2016. The inspection revealed issues with method validation, specifically concerning the inconsistent use of blank urine lots in bioequivalence studies. This indicates a potential lack of control over critical analytical processes.
- Company
- Integris Bioservices LLC
- Product Type
- Drugs
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ID · 114bc71a-2394-42ca-b202-1d48aab68a9f