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FDA Inspection
•Apollo Endosurgery•July 28, 2017

Apollo Endosurgery – FDA Inspection, Jul 28, 2017

Record Details

This FDA Inspection record concerns Apollo Endosurgery, with an inspection on July 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Apollo Endosurgery
Inspection Date
July 28, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Tania E. Vizcaino (Issuing Officer)
View Company Profile

ID · b7ac069d-e35f-4f0f-aab5-de7b9b8ffab1

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1019469
FDA center
Medical Devices & Rad Health
Project area
Bioresearch Monitoring
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Apollo Endosurgery

1
DateClassificationOfficeProject area
October 5, 2018Not classifiedOffice of Inspections and Investigations
Other documents for Apollo Endosurgery
  • FDA Inspection 1121482 - 2018-10-05

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