483
Digestive Care IncDigestive Care Inc – FDA 483, May 5, 2026
Record Details
An FDA inspection of Digestive Care Inc. in Bethlehem, PA, revealed significant deficiencies in equipment cleaning and validation practices. The firm failed to demonstrate that manufacturing equipment was free of residual agents and lacked proper cleaning verification or validation studies. This raises concerns about potential contamination and the safety, identity, strength, quality, or purity of their drug products.
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