Intas Pharmaceuticals Limited

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

You failed to ensure reliability of data relating to the quality of medicines produced at your facility. Our inspection revealed serious deviations, including but not limited to, inadequate oversight of original CGMP documents, deficient controls over computerized systems, insufficient laboratory investigations, and aborted chromatographic sequences.

Passage 2

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

Passage 3

Your firm failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)).

Passage 4

Your firm failed to have appropriate procedures for the integration of chromatographic peaks and for the review of chromatographic data.

Passage 5

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Passage 6

Your firm failed to adequately validate the manufacturing process for **(b)(4)** injection **(b)(4)** mg. Specifically, your process validation lacked an evaluation of inter-batch and intra-batch variability observed for **(b)(4)** impurities and **(b)(4)**.

Passage 7

Your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).