Recent findings
US FDA
Pro Numb Tattoo Numbing Spray, LLC
2026-04-21
Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure: Establishment of adequate batch production and control…
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US FDA
Atlantic Management Resources LTD dba. Claire Ellen Products
2023-03-14
Your firm failed to store drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity are not affected (21 CFR 211.142(b)). You failed to have adequate storage and warehousing of drug products. For example, although a supplier’s certificate of analysis (COA) for a bulk drug stated that the drug is sensitive to heat, sunlight, and moisture, you failed to monitor storage conditions for the drug, including for temperature and humidity. You also acknowledged that there were inadequate storage conditions for drug products, and for your containers and closures. The holding of drug products must be performed under appropriate conditions so that the identity, strength, quality, and purity are not affected.
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US FDA
Infusion Options, Inc.
2021-11-09
Your firm failed to follow written procedures regarding storage and warehousing of drug products (21 CFR 211.142).
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These findings are a record of the moment each document was published. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out — do not read them as the current state; check the regulator's official announcements for the latest status. Findings are extracted automatically from the regulator's published documents, and section citations are counted exactly as written in the source. “View official source” on each case links directly to that document.
