FDA Inspection 1009888 — Cita International USA
The FDA completed an inspection of Cita International USA on April 27, 2017 in Glendale, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 27, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Glendale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |