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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 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
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 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
Voluntary Action Indicated (VAI)
Feb 7, 2025
Drugs · Drug Quality Assurance
9 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 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce 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.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity.
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 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
21 CFR 211.170(b). Drug product reserve containers Drug product reserve samples are not stored in an immediate container-closure system that has essentially the same characteristics as the marketed product.
21 CFR 211.194(d). Laboratory equipment calibration records Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
Voluntary Action Indicated (VAI)
Dec 15, 2023
Drugs · Drug Quality Assurance
3 cited references
21 CFR 211.192. No written record of investigation Written records are not always made of investigations into unexplained discrepancies.
21 CFR 211.84(d)(3). Establish reliability of supplier's C of A Establishment of the reliability of the container and closure supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
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)
Feb 21, 2020
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)
May 17, 2018
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Feb 6, 2015
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
21 CFR 211.68(a). Written calibration / inspection records not kept Records of the inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining appropriate storage 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
Arnprior, Canada. Every inspection FDA has posted for the site, with its outcome and cited regulations.