FDA Inspection 885413 — Martin Avenue Pharmacy, Inc.
The FDA completed an inspection of Martin Avenue Pharmacy, Inc. on July 21, 2014 in Naperville, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 21, 2014
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Naperville, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 17002 | FDCA 501(a) | Drug Field Exam |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |