FDA Inspection 1304528 — ARMOR PLAST PVT LTD
The FDA completed an inspection of ARMOR PLAST PVT LTD on February 26, 2026 in Bengaluru. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 26, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bengaluru (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 23039 | ISO 13485:2016 Clause 4.2.4 | Document Control Procedure Inadequate |
| 23213 | ISO 13485:2016 Clause 8.2.1 | Information gathered in feedback process not used as input into risk management |
| 23252 | ISO 13485:2016 Clause 8.4 | Analysis of data not used as input for QMS improvement where necessary |