FDA Inspection 561460 — Apotheca, Inc.
The FDA completed an inspection of Apotheca, Inc. on January 29, 2009 in Phoenix, AZ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 29, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |