FDA Inspection 985991 — Cascadia Manufacturing Inc
The FDA completed an inspection of Cascadia Manufacturing Inc on March 1, 2016 in Bellevue, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 20 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 1, 2016
- Fiscal Year
- 2016
- 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 |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2016 | 21 CFR 211.188(b)(4) | Weights and Measures of Components Used |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |