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FDA establishment 3004158845, Saint-Laurent, Canada. Part of Lernapharm (Loris)'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 1
Last inspection ended: May 6, 2022
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 211.125(c). Label reconciliation discrepancies evaluation/investigation Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not evaluated.
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. Electronic records are used, but they do not meet systems validation requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Voluntary Action Indicated (VAI)
Dec 12, 2017
Drugs · Drug Quality Assurance
6 cited references
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 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining expiration dates.
21 CFR 211.166(a)(3). Valid stability test methods The written stability program for drug products does not include meaningful and specific test methods.
21 CFR 211.167(a). Sterility/pyrogen-free testing Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
21 CFR 211.115(a). Reprocessing procedures not written or followed Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written.
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 drug product containers conform to appropriate standards of identity, strength, quality and purity.
Official Action Indicated (OAI)
Nov 6, 2014
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
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
Saint-Laurent, Canada. Part of