FDA Inspection 749702 — Professional Disposables International, Inc.
The FDA completed an inspection of Professional Disposables International, Inc. on October 18, 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 18, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orangeburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |