743248
Chemisphere Corporation — FEI 1000158477
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 16, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |
| 4376 | 21 CFR 211.188(b)(4) | Weights and measures of components used |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |