FDA Inspection 1042002 — Grisi Hnos, S.A. De C.V.
The FDA completed an inspection of Grisi Hnos, S.A. De C.V. on Feb 23, 2018 in Ciudad De Mexico. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 23, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ciudad De Mexico (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |