FDA Inspection 942326 — Chen Shwezin, Inc. dba Park Compounding Pharmacy
The FDA completed an inspection of Chen Shwezin, Inc. dba Park Compounding Pharmacy on September 11, 2015 in Westlake Village, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 11, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Westlake Village, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |