FDA Inspection
ProMED Concepts, LLCProMED Concepts, LLC – FDA Inspection, Feb 1, 2018
Record Details
This FDA Inspection record concerns ProMED Concepts, LLC, with an inspection on February 1, 2018, issued by the New Orleans District Office, covering medical devices & rad health.
- Person
- Bonnie E. Conley (Issuing Officer)
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ID · e0707046-2f43-465b-b879-2b8781154608
Inspection Facts
- Inspection number
- 1039492
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of ProMED Concepts, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2025 | VAI | New Orleans District Office | Compliance: Medical Devices |
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