FDA Inspection 861942 — Kutol Products Company, Inc.
The FDA completed an inspection of Kutol Products Company, Inc. on January 2, 2014 in Sharonville, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 2, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sharonville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |