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FDA establishment 3010034070, Woodstock, Canada. Part of Tranzonic Companies's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 2
Official action indicated: 1
Last inspection ended: Apr 25, 2025
Warning letters: 1
Import refusals since 2024: 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 211.65(a). Equipment construction - reactive surfaces Equipment surfaces that contact in-process materials and drug products are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
21 CFR 211.25(a). GMP Training Frequency GMP training is not conducted to assure that employees remain familiar with CGMP requirements applicable to them.
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 211.192. 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 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.111. Establishment of time limitations Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
21 CFR 211.166(a)(4). Testing in same container - closure system The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration and checking of mechanical equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
21 CFR 211.186(b)(9). Manufacturing Instructions and Specifications The master production and control records are deficient in that they do not include complete manufacturing, instructions and procedures.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.101(d). Component addition checked by 2nd person Each component is not added to a batch by one person and verified by a second person.
21 CFR 211.194(a)(4). Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
21 CFR 211.186(b)(8). Description of containers, labels, et. al. Master production and control records lack a specimen or copy of each label and all other labeling.
Official Action Indicated (OAI)
Jun 6, 2019
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Woodstock, Canada. Part of