FDA Inspection 1240753 — Chemblend of America LLC
The FDA completed an inspection of Chemblend of America LLC on June 7, 2024 in Bensenville, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 7, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bensenville, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |