FDA Inspection 696428 — Professional Disposables International, Inc.
The FDA completed an inspection of Professional Disposables International, Inc. on Oct 21, 2010 in Orangeburg, NY. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 21, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- 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 |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |