FDA Inspection 1173827 — Biocosmetica Excel Argentina S.R.L.
The FDA completed an inspection of Biocosmetica Excel Argentina S.R.L. on Jul 7, 2022 in San Justo. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 7, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Justo (Argentina)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |