FDA Inspection 969547 — Reliable Rexall-A Compounding Pharmacy
The FDA completed an inspection of Reliable Rexall-A Compounding Pharmacy on March 29, 2016 in San Francisco, CA. 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
- March 29, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Francisco, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4417 | 21 CFR 211.204 | Associated batches implicated, investigated |