FDA Inspection
MELOQ ABMELOQ AB – FDA Inspection, Mar 9, 2023
Record Details
This FDA Inspection record concerns MELOQ AB, with an inspection on March 9, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Jeffrey S. Buckser
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ID · bfe5cd46-4daf-43ae-84c8-0bc8ec4cbe9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199271
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
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