FDA Inspection
Haelan Medical, IncHaelan Medical, Inc – FDA Inspection, Jun 20, 2018
Record Details
This FDA Inspection record concerns Haelan Medical, Inc, with an inspection on June 20, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 85f975ce-e981-4d18-8693-e88f2bcba61b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056285
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
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