FDA Inspection 976852 — Isomeric Pharmacy Solutions, LLC
The FDA completed an inspection of Isomeric Pharmacy Solutions, LLC on June 29, 2016 in Salt Lake City, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 29, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |