Drug factory · FDA FEI 3002808384
Sun Pharma Canada Inc.
130 East Dr, Brampton, Canada
No problems found at FDA's last inspection, Mar 27, 2026.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2011: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 27, 2026 | No problems found | Drug Quality Assurance | — |
| Sep 20, 2024 | No problems found | Bioresearch Monitoring | — |
| Sep 16, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| May 3, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jul 29, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 28, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 11, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 16, 2022 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
May 3, 2019 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. - No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications. - Description and Identification of Samples 21 CFR 211.194(a)(1)
Laboratory records are deficient in that they do not include a date sample received for testing.
Registered with FDA for: analysis; label; manufacture; pack.