FDA Inspection 982470 — Destileria Serralles, Inc.
The FDA completed an inspection of Destileria Serralles, Inc. on August 9, 2016 in Mercedita, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 9, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mercedita, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3568 | 21 CFR 211.84(d)(3) | Container/closure visual identification |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |