483
Gasco Industrial Corp.FDA 483 - Gasco Industrial Corp. - October 18, 2022
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Gasco Industrial Corp. in Gurabo, PR, was cited for significant deficiencies in its manufacturing and quality control systems for drug products like hand sanitizers and antibacterial soap. The inspection revealed failures in product testing, raw material identification, adherence to specifications, and a general lack of written procedures and facility maintenance, indicating a severe lack of GMP compliance.
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