FDA Inspection 831650 — The Original Cream Company
The FDA completed an inspection of The Original Cream Company on May 14, 2013 in Magnolia, AR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 14, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Magnolia, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 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 |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |