FDA Inspection 585537 — APP Pharmaceuticals, LLC.
The FDA completed an inspection of APP Pharmaceuticals, LLC. on May 28, 2009 in Barceloneta, PR. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 28, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Barceloneta, PR (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3594 | 21 CFR 211.110(d) | Rejected in-process materials not quarantined |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |