FDA Inspection 756691 — MYA International, Inc
The FDA completed an inspection of MYA International, Inc on December 12, 2011 in Chula Vista, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 12, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chula Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |