Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3001617666.
Observations10
Issue DateMay 09, 2025
Status1 Related Warning Letter
Establishment TypeDrug Manufacturer
Related Inspections10
Establishment Details
Firm
Apotex Inc.
Location
Richmond Hill, -, Canada
FEI Number
3001617666
Establishment Type
Drug Manufacturer
Product Type
Drugs
Issue Date
May 09, 2025
Country
Canada
Inspection History, 2012 to 2025
NAI5
VAI3
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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