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21 CFR 211.22(c). Approve or reject procedures or specs The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
21 CFR 211.94(a). Reactive/Additive/Absorptive Containers/Closures Drug product containers or closures are additive so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Voluntary Action Indicated (VAI)
Apr 20, 2018
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
FDCA 503B(a)(10). Drug product label, outsourcer facility The labels of your outsourcing facility's drug products are deficient.
21 CFR 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
21 CFR 211.42(c)(10)(vi). Equipment to control conditions Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Phoenix, Arizona, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.