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21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that components conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.25(b). Supervisor Training/Education/Experience Individuals responsible for supervising the manufacture and processing of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
21 CFR 211.84(d)(1). Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.165(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
Voluntary Action Indicated (VAI)
Jan 24, 2020
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
Voluntary Action Indicated (VAI)
Dec 9, 2016
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
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
Pointe-Claire, Canada. Every inspection FDA has posted for the site, with its outcome and cited regulations.