FDA Inspection
Filmecc Development CenterFilmecc Development Center – FDA Inspection, Jan 23, 2025
Record Details
This FDA Inspection record concerns Filmecc Development Center, with an inspection on January 23, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Filmecc Development Center
- Inspection Date
- January 23, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · a57ecd27-3f4a-4956-9ca0-b4e2a6502f49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1259494
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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