FDA Inspection
New England Ortho Laboratory, Inc.New England Ortho Laboratory, Inc. – FDA Inspection, Feb 18, 2022
Record Details
This FDA Inspection record concerns New England Ortho Laboratory, Inc., with an inspection on February 18, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 18, 2022
- Product Type
- Devices
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ID · b00fd40a-358f-45d8-aeab-a81b3f3a50a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1162845
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.184DHR content
- 21 CFR 820.20(c)Management review dates
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