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FDA Inspection
•Conair LLC•May 31, 2013

FDA Inspection 835058 - Conair LLC - May 31, 2013

Record Details

This FDA Inspection record concerns Conair LLC, with an inspection on May 31, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company
Conair LLC
Inspection Date
May 31, 2013
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · cd2c013b-047d-47f0-a5d2-f11a8b7338b7

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
835058
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

8
  1. 21 CFR 803.50(a)(2)Individual Report of Malfunction
  2. 21 CFR 820.198(c)Investigation of device failures
  3. 21 CFR 820.198(d)Evaluation, timeliness, identification
  4. 21 CFR 820.100(a)Lack of or inadequate procedures
  5. 21 CFR 820.30(a)Design control - no procedures
  6. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  7. 21 CFR 820.186QSR
  8. 21 CFR 803.17Lack of Written MDR Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Conair LLC

5
DateClassificationOfficeProject area
October 22, 2025NAINew England District OfficePostmarket Assurance: Medical Devices
July 19, 2023NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
February 1, 2018NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
February 27, 2015NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
January 21, 2014OAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Conair LLC
  • FDA Inspection 1288424 - 2025-10-22
  • FDA Inspection 1210886 - 2023-07-19
  • FDA Inspection 1039792 - 2018-02-01
  • FDA Inspection 923367 - 2015-02-27
  • FDA Inspection 862842 - 2014-01-21

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