FDA Inspection 1160813 — American Chinese Medicine Association, Inc
The FDA completed an inspection of American Chinese Medicine Association, Inc on Jan 20, 2022 in Aurora, IL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 20, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aurora, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1770 | 21 CFR 211.137(d) | Expiration date location on labeling |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |