FDA Inspection 1275297 — Procter & Gamble Manufacturing Mexico, S. de R.L. de C.V.
The FDA completed an inspection of Procter & Gamble Manufacturing Mexico, S. de R.L. de C.V. on June 27, 2025 in Naucalpan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 27, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Naucalpan (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |