FDA Inspection 898915 — Distribuidora Comercial Jafra S.A. De C.V.
The FDA completed an inspection of Distribuidora Comercial Jafra S.A. De C.V. on Sep 29, 2014 in Santa Rosa Jauregui. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 29, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Rosa Jauregui (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |