FDA Inspection 655435 — Chemisphere Corporation
The FDA completed an inspection of Chemisphere Corporation on April 5, 2010 in Saint Louis, MO. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2203 | 21 CFR 211.186(b)(7) | Theoretical Yield and Percentages |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |