FDA Inspection 801788 — Kutol Products Company, Inc.
The FDA completed an inspection of Kutol Products Company, Inc. on October 11, 2012 in Sharonville, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 11, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Sharonville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2569 | 21 CFR 211.198(b) | Maintenance of Complaint File |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |