FDA Inspection 1170081 — BOEHRINGER INGELHEIM PROMECO S.A. De C.V.
The FDA completed an inspection of BOEHRINGER INGELHEIM PROMECO S.A. De C.V. on May 20, 2022 in Xochimilco. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 20, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Xochimilco (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 3554 | 21 CFR 211.48(a) | Potable water standards not met |