FDA Inspection 1130482 — Sky Systems Co., Inc.
The FDA completed an inspection of Sky Systems Co., Inc. on September 30, 2020 in Ontario, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 30, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ontario, CA (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 |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 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 |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |