Cipla Faces USFDA Scrutiny: Eight Observations Found
Cipla's Bengaluru plant faces scrutiny as the USFDA issues eight observations following an inspection. The examination took place from November 7-13. Cipla commits to working with the USFDA to address these findings and ensure compliance within the expected timelines, demonstrating their dedication to regulatory standards.
- Country:
- India
Cipla, a prominent player in the pharmaceutical industry, faces regulatory scrutiny as the US Food and Drug Administration (USFDA) issues eight observations following an inspection of its Bengaluru-based plant. The inspection, conducted from November 7 to November 13, has put Cipla in the spotlight regarding compliance issues.
The Mumbai-based drug manufacturer acknowledged the evaluation and confirmed the receipt of these observations documented in Form 483. This marks a critical period for Cipla as it works to rectify and address the highlighted concerns.
In a statement to BSE, Cipla emphasized their commitment to closely collaborate with the USFDA. The company plans to tackle each observation comprehensively and within the stipulated timeframe, underscoring its dedication to uphold regulatory standards and maintain the trust of its stakeholders.
(With inputs from agencies.)
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