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FDA establishment 3001617666, Richmond Hill, Canada. Part of Apotex's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 11
Official action indicated: 2
Last inspection ended: May 9, 2025
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
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 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.160(a). Following/documenting laboratory controls Established sampling plans and test procedures are not followed and documented at the time of performance.
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are.
21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
21 CFR 211.110(a). Written in-process control procedures Written procedures are not established that describe the tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
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.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Official Action Indicated (OAI)
Mar 8, 2024
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Mar 24, 2023
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Sep 14, 2022
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Voluntary Action Indicated (VAI)
Jun 28, 2019
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Mar 22, 2019
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Apr 11, 2017
Drugs · Drug Quality Assurance
2 cited references
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.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Voluntary Action Indicated (VAI)
Mar 4, 2015
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Aug 30, 2013
Drugs · Drug Quality Assurance
7 cited references
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture of a drug product lack the education and training required to perform their assigned functions.
21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
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.
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 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
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)
Oct 26, 2012
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Aug 17, 2010
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Richmond Hill, Canada. Part of