FDA Inspection 554235 — Innovative Chemical Corporation
The FDA completed an inspection of Innovative Chemical Corporation on Jan 27, 2009 in Cottage Grove, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 27, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cottage Grove, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1791 | 21 CFR 211.80(c) | Storage off Floor, Spaced Suitably |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |