Groupe PARIMA Inc. FDA Inspection Record
Groupe PARIMA Inc. is an FDA-registered facility (FEI 3003773810) located in Montreal, CA. Registered operations: LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Aug 25, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (4 VAI, 2 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 |
|---|---|---|
| Aug 25, 2023 | Voluntary Action Indicated (VAI) | Authority lacking to review records, investigate errors (21 CFR 211.22(a)) Cleaning/maintenance records not kept (21 CFR 211.67(c)) Computer control of master formula records (21 CFR 211.68(b)) SOPs not followed / documented (21 CFR 211.100(b)) and 2 more |
| Jan 24, 2020 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Equipment Design, Size and Location (21 CFR 211.63) Calibration/Inspection/Checking not done (21 CFR 211.68(a)) QC- required operations equipment, instruments, controls (21 CFR 111.105(i)) and 4 more |
| Apr 27, 2018 | Voluntary Action Indicated (VAI) | Calibration/Inspection/Checking not done (21 CFR 211.68(a)) Buildings not maintained in good state of repair (21 CFR 211.58) Backup data not assured as exact and complete (21 CFR 211.68(b)) |
| Jan 22, 2016 | No Action Indicated (NAI) | No citations listed |
| Aug 30, 2013 | No Action Indicated (NAI) | No citations listed |
| Sep 13, 2011 | Voluntary Action Indicated (VAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Control procedures to monitor and validate performance (21 CFR 211.110(a)) Scientifically sound laboratory controls (21 CFR 211.160(b)) Annual visual exams of drug products (21 CFR 211.170(b)) and 1 more |
FDA record score
7 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
4 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Aug 25, 2023 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Jan 24, 2020 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Apr 27, 2018 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Sep 13, 2011 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Groupe Parima Inc.
- Location
- Montreal (CA)
- Registration Expires
- Dec 31, 2027
- Operations
- LABEL; MANUFACTURE; PACK
- Source
- decrs