FDA Inspection
Paterson Pearl Dental Studio, LLCPaterson Pearl Dental Studio, LLC – FDA Inspection, May 19, 2009
Record Details
This FDA Inspection record concerns Paterson Pearl Dental Studio, LLC, with an inspection on May 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 19, 2009
- Product Type
- Devices
View Company Profile
ID · f838946f-279f-4bf3-b6b1-dc203f797379
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 595607
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.