FDA Inspection 1195684 — Avlon Industries, Inc
The FDA completed an inspection of Avlon Industries, Inc on January 24, 2023 in Melrose Park, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 24, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Melrose Park, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |