Prodimed Plastimed Division — FDA Facility Profile
Prodimed Plastimed Division is an FDA-inspected facility (FEI 3003781614) located in Le Plessis-Bouchard, FR. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Nov 15, 2022: No Action Indicated (NAI)
- Inspections on record
- 3 (2 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
- Recalls as the recalling firm
- 1, latest May 27, 2020
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 15, 2022 | No Action Indicated (NAI) | No citations listed |
| Feb 27, 2020 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design output - Lack of or inadequate procedures (21 CFR 820.30(d)) Lack of or inadequate procedures - Acceptance activities (21 CFR 820.80(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 3 more |
| Mar 12, 2015 | Voluntary Action Indicated (VAI) | Documentation (21 CFR 820.80(e)) Nonconforming product control (21 CFR 820.90(a)) Equipment control activity documentation (21 CFR 820.72(a)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 27, 2020 | Class II | Z-2487-2020 | Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x… and 5 more products Lack of assurance of sterility |
Facility details
- Company
- Prodimed Plastimed Division
- Location
- Le Plessis-Bouchard (FR)
- Source
- inspections