FDA Inspection 1026086 — Multaler Et Cie S.A.S.
The FDA completed an inspection of Multaler Et Cie S.A.S. on September 22, 2017 in Argenteuil. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 22, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Argenteuil (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |