FDA Inspection
Triumvirate Environmental, Inc.Triumvirate Environmental, Inc. – FDA Inspection, Mar 18, 2019
Record Details
This FDA Inspection record concerns Triumvirate Environmental, Inc., with an inspection on March 18, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f091df9a-8bb2-4e49-916c-5cbe2fb2fedf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083220
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.25(b)Training records
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.184(f)DHR - UDI not included
- 21 CFR 803.17Lack of Written MDR Procedures
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