FDA Inspection 835774 — Americare Compounding, LLC.
The FDA completed an inspection of Americare Compounding, LLC. on June 19, 2013 in Garden City South, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 19, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Garden City South, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3551 | 21 CFR 211.46(d) | Penicillin air handling systems not kept separate |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |