FDA Inspection 695768 — Massco Dental
The FDA completed an inspection of Massco Dental on October 29, 2010 in Rogers, AR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 29, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rogers, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |