FDA Inspection
GCE S.R.O.GCE S.R.O. – FDA Inspection, Mar 14, 2024
Record Details
This FDA Inspection record concerns GCE S.R.O., with an inspection on March 14, 2024, covering devices.
- Company
- GCE S.R.O.
- Inspection Date
- March 14, 2024
- Product Type
- Devices
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ID · 76e6b278-71a4-47fd-81df-17885a945855
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1233579
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.72(b)Remedial action
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