FDA Inspection 1063748 — LABORATORIOS QUIFARMA S.A.
The FDA completed an inspection of LABORATORIOS QUIFARMA S.A. on Aug 29, 2018 in San Miguel Petapa. 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). 2 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 29, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- San Miguel Petapa (Guatemala)
Citations
| ID | CFR | Description |
|---|---|---|
| 1040 | 21 CFR 113.10 | Operators |
| 4529 | 21 CFR 108.35(c)(2)(ii) | Process change reporting to CFSAN |