FDA Inspection
Spectronics CorpSpectronics Corp – FDA Inspection, Jan 30, 2020
Record Details
This FDA Inspection record concerns Spectronics Corp, with an inspection on January 30, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spectronics Corp
- Inspection Date
- January 30, 2020
- Product Type
- Devices
View Company Profile
ID · e3e6defe-89c3-4ffb-b6f5-f4d5c3227af5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1116900
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR content
- 21 CFR 820.184(f)DHR - UDI not included
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spectronics Corp
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Spectronics Corp
- FDA Inspection 1006288 - 2017-04-05
- FDA Inspection 632425 - 2009-12-07
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