FDA Inspection 887950 — Massco Dental
The FDA completed an inspection of Massco Dental on July 18, 2014 in Rogers, AR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 18, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rogers, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |