FDA Inspection 634732 — Kleen Test Products Corporation
The FDA completed an inspection of Kleen Test Products Corporation on Nov 30, 2009 in Port Washington, WI. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 30, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Port Washington, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |