Dr. Reddy's Laboratories Says "FDA Today Completed A Product Specific Pre-Approval Inspection At Our Biologics Manufacturing Facility. The Inspection Was Conducted From Oct 4-12, We Have Been Issued A Form 483 With 9 Observations"
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The FDA has completed a product-specific pre-approval inspection at Dr. Reddy's Laboratories' biologics manufacturing facility. The inspection, which took place from October 4-12, resulted in the issuance of a Form 483 with 9 observations.
October 12, 2023 | 1:24 pm
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Dr. Reddy's Laboratories received a Form 483 with 9 observations from the FDA following a pre-approval inspection of its biologics manufacturing facility.
The issuance of a Form 483 by the FDA indicates that the agency has found conditions that may constitute violations of the Food, Drug, and Cosmetic Act and related Acts. This could potentially impact Dr. Reddy's Laboratories' operations and reputation, leading to a negative impact on its stock price in the short term.
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