FDA Inspection 720642 — Professional Disposables International, Inc.
The FDA completed an inspection of Professional Disposables International, Inc. on Apr 20, 2011 in Orangeburg, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Apr 20, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Orangeburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |