483
OHM Pharma, Inc.OHM Pharma, Inc. – FDA 483, Apr 29, 2025
Record Details
An FDA inspection of OHM Pharma, Inc. in Mineral Wells, TX, a manufacturer of non-sterile liquid OTC drug products, intermediates, and APIs, revealed significant deficiencies. The firm failed to establish adequate cleaning procedures, use appropriately designed equipment, perform process validation, and implement a stability monitoring program. These observations indicate serious concerns regarding the firm's manufacturing controls and product quality.
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ID · 0e3c0e4a-7131-4158-9648-6d81a14f82da
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