FDA Inspection 1086039 — Dermazone LLC
The FDA completed an inspection of Dermazone LLC on April 11, 2019 in Saint Petersburg, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 11, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Petersburg, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |