FDA Inspection 1095002 — Shertech Pharmacy
The FDA completed an inspection of Shertech Pharmacy on July 2, 2019 in Easley, SC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 2, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Easley, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 18943 | FDCA 501(a)(2)(A) | Personnel in aseptic processing, non-sterile gloves |
| 18961 | FDCA 501(a)(2)(A) | Air flow quality, higher classified area |
| 18971 | FDCA 501(a)(2)(A) | No sporicidal agents, cleanroom and ISO 5 area |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |