FDA Inspection 702362 — Cispharma Inc.
The FDA completed an inspection of Cispharma Inc. on January 24, 2011 in Cranbury, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 24, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cranbury, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4311 | 21 CFR 211.84(c)(4) | Compositing of Sub Samples |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4330 | 21 CFR 211.130(e) | Packaging line inspection documentation |