Purdue Pharma FDA Inspection Record
Purdue Pharma is an FDA-inspected facility (FEI 3003287869) located in Pickering, CA. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 26, 2019: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (4 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 26, 2019 | Voluntary Action Indicated (VAI) | SOPs not followed / documented (21 CFR 211.100(b)) Approval and review of procedures (21 CFR 211.100(a)) |
| Aug 4, 2017 | No Action Indicated (NAI) | No citations listed |
| Jul 10, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 13, 2013 | Voluntary Action Indicated (VAI) | SOPs not followed / documented (21 CFR 211.100(b)) Absence of Written Procedures (21 CFR 211.100(a)) Written complaint record must include (21 CFR 211.198(b)(1)) |
| Jul 15, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Purdue Pharma
- Location
- Pickering (CA)
- Source
- inspections