FDA Inspection 1022605 — Burkhart Dental Supply Co (The)
The FDA completed an inspection of Burkhart Dental Supply Co (The) on Aug 21, 2017 in Grand Prairie, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 21, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Grand Prairie, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12419 | 21 CFR 1271.265(a) | Evaluation--microorganisms, damage |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |