FDA 483 - APDM Pharmaceuticals Private Limited - June 12, 2026
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APDM Pharmaceuticals Private Limited in Ahmedabad, India, received a Form 483 for deficiencies related to equipment design and qualification. The firm failed to adequately qualify operating parameters for equipment used in the commercial manufacturing of drug products. Additionally, sensors on the bottle filling and capping machines were not properly challenged to detect critical errors and defects, indicating a lack of appropriate validation for manufacturing and packaging equipment.
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