FDA Inspection 1151152 — Alick's Home Medical Equipment, Inc.
The FDA completed an inspection of Alick's Home Medical Equipment, Inc. on September 3, 2021 in South Bend, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 3, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- South Bend, IN (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 |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2569 | 21 CFR 211.198(b) | Maintenance of Complaint File |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |