FDA Inspection
Barton SachsBarton Sachs – FDA Inspection, Feb 19, 2009
Record Details
This FDA Inspection record concerns Barton Sachs, with an inspection on February 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Barton Sachs
- Inspection Date
- February 19, 2009
- Product Type
- Devices
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ID · a8eff3aa-eba9-4d37-b508-acd243c3ebcc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 571701
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.150(a)(1)Investigator report of unanticipated adverse effects
- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(5)Additional investigator records FDA requires
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