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FDA Inspection
•APEX DENTAL SLEEP LAB LLC•February 22, 2024

APEX DENTAL SLEEP LAB LLC – FDA Inspection, Feb 22, 2024

Record Details

This FDA Inspection record concerns APEX DENTAL SLEEP LAB LLC, with an inspection on February 22, 2024, issued by the Center for Devices and Radiological Health, covering devices.

Company
APEX DENTAL SLEEP LAB LLC
Inspection Date
February 22, 2024
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Juanj Wu (Issuing Officer)
View Company Profile

ID · 8f95f872-9946-4b16-977e-86c2fa18546a

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1231989
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

4
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  3. 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
  4. 21 CFR 801.40(a)Form of a unique device identifier

Full citation text and observation details available on the Dashboard.

Other FDA inspections of APEX DENTAL SLEEP LAB LLC

1
DateClassificationOfficeProject area
January 22, 2018Not classifiedLos Angeles District Office
Other documents for APEX DENTAL SLEEP LAB LLC
  • FDA Inspection 1049546 - 2018-01-22

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