FDA Inspection 996125 — Okamoto Rubber Products Co., Ltd.
The FDA completed an inspection of Okamoto Rubber Products Co., Ltd. on Dec 22, 2016 in Khlong Luang. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 22, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Khlong Luang (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |