483
Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. – FDA 483, Jun 21, 2019
Record Details
Dr. Reddy's Laboratories Ltd. in Visakhapatnam, India, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies related to the establishment of acceptance criteria for validation activities and the lack of scientific data supporting finished product release specifications. Additionally, the firm failed to correctly translate device design into production specifications, specifically concerning Acceptance Quality Limit for component critical dimensions.
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ID · 9fef49f9-5671-43c5-a085-c4329aec5a13
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