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Isopropyl rubbing alcohol did not include an appropriate assay test for active ingredient content or microbiological testing.
August 28, 2024
By: TOM BRANNA
Editor
Nowrez & Ismail Shukri Company, Amman, Jordan, received a Warning Letter from the US Food and Drug Administration for “significant” violations pursuant to section 704(a)(4) of the FD&C Act. These violations include: • Failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)...
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