Apotex Inc.: due-diligence report
Public-record summary and buyer worksheet. Records can be incomplete; a listing is not product approval, an audit result or a guarantee of suitability. This report updates as source records change. Print a dated copy to retain the version you reviewed.
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Profile last verified: Oct 26, 2026. Report printed / reviewed on: ____________________
Certifications and licences
Health Canada natural health product site licence (GMP)
Issuer: Health Canada. Registry status: active. Checked: Oct 26, 2026.
Reference: 301993. Expiry: Not recorded.
Scope: Not recorded here; confirm with the registry and manufacturer.
Registry source: https://www.drug-inspections.canada.ca/nhp/inspectionDetail-en.html?lang=en&insNumber=82796Facilities
Apotex Inc., 150 Signet Drive, Toronto, ON, M9L 1T9, CA — manufacturing; source: Health Canada; checked Oct 26, 2026.
FDA inspection history
Dataset date: Oct 22, 2026. Facility records are matched by company and location; confirm that the site is the one in your quote. FDA inspection source.
No matched inspections in the imported dataset. This does not establish that the facility has never been inspected.
FDA recalls
Dataset date: Oct 27, 2026. Recall matches use company names and may concern a different product or facility.
No matched recall events in the imported dataset. This is not proof of a recall-free history.
Company website claims — not registry verified
Last website check: Unavailable / not checked.
No current website claims available here. Capabilities and commercial terms remain unknown until confirmed with the company.
Evidence to request from the manufacturer
Public records cannot answer these questions. Mark each item after reviewing the evidence. Blank means not assessed, not a failed audit. Notes entered here are not saved or included in a shared URL.
Request role-specific training records and the named quality contact.
21 CFR 111.12Request a site walkthrough, sanitation controls and equipment maintenance records (also §111.25).
21 CFR 111.20Request written identity, purity, strength, composition and contaminant specifications for your product.
21 CFR 111.70Ask how each dietary ingredient is identified and how suppliers and certificates of analysis are qualified.
21 CFR 111.75Request quality control procedures, release authority and handling of deviations and rejected batches.
21 CFR 111.105Request the approved product-specific master manufacturing record and change-control process.
21 CFR 111.205Review a completed batch record with traceability to components, processing and release.
21 CFR 111.255Request scientifically valid test methods, sampling plans and laboratory controls for your specifications.
21 CFR 111.315Request procedures that prevent label mix-ups and control packaging and label reconciliation.
21 CFR 111.403Ask how storage conditions protect identity, purity, strength and composition during holding and distribution.
21 CFR 111.453Request complaint review and investigation procedures; discuss returned-product controls under §111.503.
21 CFR 111.553Confirm retention and access to records supporting your batches.
21 CFR 111.605