FDA Inspection 1178803 — Massco Dental
The FDA completed an inspection of Massco Dental on September 2, 2022 in Rogers, AR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 2, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rogers, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |