FDA Inspection 1215638 — Innolatex Sdn. Bhd.
The FDA completed an inspection of Innolatex Sdn. Bhd. on Jul 27, 2023 in Port Klang. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 27, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Port Klang (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |