Sun Pharma Canada Inc. — FDA Facility Profile
Sun Pharma Canada Inc. is an FDA-registered facility (FEI 3002808384) located in Brampton, CA. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Mar 27, 2026: No Action Indicated (NAI)
- Inspections on record
- 7 (4 VAI, 3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Feb 5, 2009
- Recalls as the recalling firm
- 3, latest Nov 6, 2023
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 27, 2026 | No Action Indicated (NAI) | No citations listed |
| Sep 20, 2024 | No Action Indicated (NAI) | No citations listed |
| Sep 16, 2022 | Voluntary Action Indicated (VAI) | SOPs not followed / documented (21 CFR 211.100(b)) Written in-process control procedures (21 CFR 211.110(a)) |
| May 3, 2019 | Voluntary Action Indicated (VAI) | SOPs not followed / documented (21 CFR 211.100(b)) Description and Identification of Samples (21 CFR 211.194(a)(1)) No written record of investigation (21 CFR 211.192) |
| Jul 29, 2016 | No Action Indicated (NAI) | No citations listed |
| Feb 28, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 11, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Nov 6, 2023 | Class III | D-0089-2024 | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd… Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the… |
| Sep 13, 2016 | Class II | D-0116-2017 | Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc… and 1 more product Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation). |
| Aug 5, 2015 | Class III | D-1370-2015 | Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro… Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time… |
Facility details
- Company
- Sun Pharma Canada Inc.
- Location
- Brampton (CA)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs