FDA Inspection 612736 — MYA International, Inc
The FDA completed an inspection of MYA International, Inc on September 18, 2009 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 18, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chula Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4376 | 21 CFR 211.188(b)(4) | Weights and measures of components used |