FDA Inspection
MERIDIAN MEDICAL DOOMERIDIAN MEDICAL DOO – FDA Inspection, Sep 17, 2026
Record Details
This FDA Inspection record concerns MERIDIAN MEDICAL DOO, with an inspection on September 17, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- MERIDIAN MEDICAL DOO
- Inspection Date
- September 17, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · ceb3b66b-c773-40bd-afef-5f3cefa33a96
Inspection Facts
- Inspection number
- 1338222
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.35(a)Records for complaints involving failure to meet specifications not maintained
- ISO 13485:2016 Clause 4.2.4Document Control Procedure Inadequate
- ISO 13485:2016 Clause 5.6.2Input to management review is incomplete
- ISO 13485:2016 Clause 7.5.1Medical device or batch records not adequate
- ISO 13485:2016 Clause 8.3.3Records not maintained for nonconforming product actions detected after delivery
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