FDA Inspection 1005888 — Isomeric Pharmacy Solutions, LLC
The FDA completed an inspection of Isomeric Pharmacy Solutions, LLC on March 24, 2017 in Salt Lake City, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 24, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |