483
ACI HealthCare LimitedACI HealthCare Limited – FDA 483, Apr 1, 2022
Record Details
An FDA inspection of ACI HealthCare Limited in Narayanganj, Bangladesh, revealed critical deficiencies in the firm's quality control and data integrity programs. Observations included incomplete laboratory records, a lack of written procedures for the quality control unit, and inadequate investigations into out-of-specification results. These issues indicate a significant failure to maintain proper control over manufacturing and testing operations for finished drug products.
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ID · 6ddbac57-90b3-407d-908d-f47bdd1f127d
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