FDA Inspection 743164 — Cascadia Manufacturing Inc
The FDA completed an inspection of Cascadia Manufacturing Inc on September 7, 2011 in Bellevue, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 7, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bellevue, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |