FDA Inspection
IDM PlasticsIDM Plastics – FDA Inspection, May 24, 2017
Record Details
This FDA Inspection record concerns IDM Plastics, with an inspection on May 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · b06b57a3-cc73-4abd-80f9-e6db00388d93
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1011809
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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