Cipla's US Unit Receives Two USFDA Form 483 Observations

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USFDA Issues Form 483 with 2 Observations to Cipla's US Plant

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News18•10-02-2026, 20:45

USFDA Issues Form 483 with 2 Observations to Cipla's US Plant

•USFDA issued Form 483 with two observations to Cipla's US-based unit InvaGen Pharmaceuticals, Inc.
•The Pre-Approval Inspection was conducted from February 2 to February 9, 2026.
•Cipla's InvaGen facility received the observations at the conclusion of the inspection.
•The company will work with USFDA to address the observations comprehensively and within the stipulated time.
•Form 483 is issued when investigators observe conditions that may violate the FD&C Act.

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