FDA Inspection 1225284 — Aerosol and Liquid Packaging, Inc.
The FDA completed an inspection of Aerosol and Liquid Packaging, Inc. on December 18, 2023 in Baltimore, MD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 18, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |