FDA Inspection 1209342 — SterRx, LLC
The FDA completed an inspection of SterRx, LLC on June 28, 2023 in Plattsburgh, NY. 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
- June 28, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Plattsburgh, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |