FDA Inspection 1238640 — Kinetics Derma Beauty, LLC
The FDA completed an inspection of Kinetics Derma Beauty, LLC on May 3, 2024 in Sugar Land, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 3, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sugar Land, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |