FDA Inspection 609014 — Cascadia Manufacturing Inc
The FDA completed an inspection of Cascadia Manufacturing Inc on August 14, 2009 in Bellevue, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 14, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Bellevue, WA (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 |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2001 | 21 CFR 211.184(b) | Component Test Records |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2196 | 21 CFR 211.186(b)(1) | Product Name and Strength |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 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) |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |