FDA Inspection 1097950 — US Specialty Formulations LLC
The FDA completed an inspection of US Specialty Formulations LLC on Jul 23, 2019 in Allentown, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 23, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |