FDA Inspection
Newmark, Inc.Newmark, Inc. – FDA Inspection, Mar 4, 2009
Record Details
This FDA Inspection record concerns Newmark, Inc., with an inspection on March 4, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Newmark, Inc.
- Inspection Date
- March 4, 2009
- Product Type
- Devices
View Company Profile
ID · 08e49d80-822c-4332-8c11-5e99b89d2e63
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 568474
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.80(b)Incoming inspection, testing, verification
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.180Availability
- 21 CFR 820.184DHR content
- 21 CFR 820.184(e)ID label, labeling
- 21 CFR 820.184(b)Quantity manufactured
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Newmark, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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