FDA Inspection 899620 — Zermat Internacional, S.A. De C.V.
The FDA completed an inspection of Zermat Internacional, S.A. De C.V. on Sep 12, 2014 in Tlalnepantla. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 12, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tlalnepantla (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |