FDA Inspection 1070425 — Kleen Concepts, LLC
The FDA completed an inspection of Kleen Concepts, LLC on Oct 30, 2018 in Scottsdale, AZ. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 30, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |