FDA Inspection 696483 — Cascadia Manufacturing Inc
The FDA completed an inspection of Cascadia Manufacturing Inc on November 16, 2010 in Bellevue, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 24 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 16, 2010
- Fiscal Year
- 2011
- 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 |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 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 |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 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 |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |