FDA Inspection 1240821 — Alive 2 Dive Company Limited
The FDA completed an inspection of Alive 2 Dive Company Limited on May 3, 2024 in Mueang. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mueang (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |