Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3021535057.
Violations4
Issue DateJun 5, 2026
Product TypeDrugs
StatusOpen
Letter Details
Firm
Sante Manufacturing Inc.
Location
516 John Street N 11A & 11B Aylmer ON N5H 2B8 Canada
FEI Number
3021535057
Country
Canada
Issue Date
June 05, 2026
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Subject
CGMP/Finished Pharmaceuticals/Adulterated
Sante Manufacturing Inc. FDA Warning Letter, June 5, 2026