483
Teligent Pharma, Inc.Teligent Pharma, Inc. – FDA 483
Record Details
An FDA inspection of Teligent, Inc. in Buena, NJ, revealed significant deficiencies in their in-vitro bioequivalence studies. The firm failed to properly retain reserve samples, maintain adequate drug accountability records, and ensure the scientific validity of their analytical methods. These issues indicate a lack of control over critical aspects of their BE study conduct and data integrity.
- Company
- Teligent Pharma, Inc.
- Product type
- drugs
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ID · c7ba4387-57bf-4488-8eb6-4612c443258e
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