FDA Inspection 1245264 — Exquisite Corporation
The FDA completed an inspection of Exquisite Corporation on August 1, 2024 in Baldwin Park, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 1, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baldwin Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |