FDA Inspection
MHC Medical Products LLCMHC Medical Products LLC – FDA Inspection, Feb 2, 2018
Record Details
This FDA Inspection record concerns MHC Medical Products LLC, with an inspection on February 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 974d2f33-6adb-4230-98eb-92dde7fe399d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039812
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.22Quality Audit/Reaudit - documentation
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Other FDA inspections of MHC Medical Products LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 23, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for MHC Medical Products LLC
- FDA Inspection 1262263 - 2025-02-26
- FDA Inspection 1180189 - 2022-09-23
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