Intas Pharmaceuticals USFDA 483
During November 22 to December 02, 2022 inspection 5 Observations shared by USFDA
Obsrevation 1
Quality control unit failed to exercise its responsibility
specifications for identity, strength, quality, and purity
Obsrevation 2
Obsrevation 2
Firm failed to ensure that laboratory records included complete data derived from all tests
Firm failed to ensure that laboratory records included complete data derived from all tests
Obsrevation 3
Obsrevation 3
Your firm failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)
Obsrevation 4
Obsrevation 4
Failed to establish adequate written procedures to assure that the drug products you manufacture have the identity, strength, quality, and purity
Obsrevation 5
Obsrevation 5
Your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods