FDA Inspection 730898 — Professional Disposables International, Inc.
The FDA completed an inspection of Professional Disposables International, Inc. on July 5, 2011 in Orangeburg, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 5, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orangeburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |