FDA Inspection
MANSBACH HEALTH TOOLS LLCMANSBACH HEALTH TOOLS LLC – FDA Inspection, Jun 2, 2026
Record Details
This FDA Inspection record concerns MANSBACH HEALTH TOOLS LLC, with an inspection on June 2, 2026, issued by the Baltimore District Office, covering medical devices & rad health.
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ID · 472194a7-c78b-4fdf-8d32-c195a629c41a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1320684
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 5.6.2Input to management review is incomplete
- ISO 13485:2016 Clause 7.1Required elements not determined in planning product realization
- ISO 13485:2016 Clause 7.3.10Design and development files not maintained
- ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 7.5.1Production controls not adequate
- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
- ISO 13485:2016 Clause 8.2.1Feedback process procedures not documented
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