FDA Inspection 1320684 — MANSBACH HEALTH TOOLS LLC
The FDA completed an inspection of MANSBACH HEALTH TOOLS LLC on June 2, 2026 in Potomac, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 2, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Potomac, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23064 | ISO 13485:2016 Clause 5.6.2 | Input to management review is incomplete |
| 23089 | ISO 13485:2016 Clause 7.1 | Required elements not determined in planning product realization |
| 23125 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not complete prior to release of product |
| 23136 | ISO 13485:2016 Clause 7.3.10 | Design and development files not maintained |
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23169 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes not documented |
| 23212 | ISO 13485:2016 Clause 8.2.1 | Feedback process procedures not documented |
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |