Drugs

Dr. Reddy’s Hit with Another FDA-483

FDA has sent Dr. Reddy’s Laboratories an eight-observation Form FDA-483 — the third inspection form in six weeks for one of its facilities in India. The current inspection ended 8/20 at the firm’s Duvvada formulations manufacturing plant in Andhra Pradesh, according to the company.

On 7/31, FDA released an FDA-483 following a 7/8-7/12 inspection at the Dr. Reddy’s Laboratories Unit 2 active pharmaceutical ingredient (API) manufacturing facility in Andhra Pradesh, India. The inspection observations were:

investigations into product complaints and out-of-specification quality control analytical results, related to finished API product quality failures, are not adequate;
preventive controls over electronic inventory and warehousing management systems are not effectively established to prevent product mix-ups and ensure traceability for the life cycle of the material;
materials are not stored under appropriate conditions and according to the manufacturer’s specifications that guarantee no adverse effect on the material’s quality, purity, and potency and are not appropriately reevaluated to determine their suitability for use after prolonged storage in and exposure to heat and humidity;
written protocols for qualification of redacted water systems are not followed; and
records were not made readily available during an FDA inspection.

An on 7/09, FDA posted a two-item FDA-483 issued following a 6/13-6/21 inspection at another Dr. Reddy’s drug manufacturing facility in Andhra Pradesh. Specific inspection observations were:

failing to establish acceptance activities prior to performance of validation activities; and
failing to correctly translate device design into production specifications.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome