1010515
Sky Systems Co., Inc. — FEI 1000331562
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 2, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ontario, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |