483
Galephar Pharmaceutical Research Inc.Galephar Pharmaceutical Research Inc. – FDA 483, Jun 1, 2021
Record Details
An FDA inspection of Galephar Pharmaceutical Research Inc. in Juncos, PR, revealed significant deficiencies in their laboratory systems and quality control unit. The firm failed to adequately validate test methods for Roxybond ARIR Tablets and did not properly assess dissolution test raw data. Additionally, the quality unit did not follow its stability sampling plan and failed to investigate a process deviation.
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ID · c2ebc29d-a183-42e3-84aa-6f364ae9f774
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