FDA Inspection 1191179 — Purechempros LLC
The FDA completed an inspection of Purechempros LLC on November 22, 2022 in Tempe, AZ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 22, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tempe, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |