483
Piramal Critical Care, Inc.FDA 483 - Piramal Critical Care, Inc. - September 27, 2023
Record Details
Piramal Critical Care, Inc. in Bethlehem, PA, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in equipment maintenance record-keeping and a lack of written procedures for production and process controls, specifically concerning an inspection unit for drug products. These issues indicate potential risks to drug product quality and compliance.
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