483
ABRYL LABORATORIES PRIVATE LIMITEDFDA 483 - ABRYL LABORATORIES PRIVATE LIMITED - November 20, 2023
Record Details
An FDA inspection of Abryl Laboratories Private Limited, a sterile drug manufacturer in Derabassi, Punjab, India, revealed significant deficiencies across multiple areas. The firm was cited for inadequate laboratory records, failure to thoroughly investigate discrepancies and out-of-specification results, and a lack of written and followed quality control unit procedures. Additionally, the inspection found issues with manufacturing process controls, including cleaning and process validation, and insufficient employee training for critical operations.
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