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FDA Inspection
•Ambi, Inc•December 14, 2017

Ambi, Inc – FDA Inspection, Dec 14, 2017

Record Details

This FDA Inspection record concerns Ambi, Inc, with an inspection on December 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Ambi, Inc
Inspection Date
December 14, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Seema S. Singh (Issuing Officer)
View Company Profile

ID · 311ce946-dac4-408d-b235-81d0da811bf0

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1035272
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.184DHR content
  2. 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 Ambi, Inc

2
DateClassificationOfficeProject area
June 13, 2025VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
February 16, 2022NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Ambi, Inc
  • FDA Inspection 1272791 - 2025-06-13
  • FDA Inspection 1163119 - 2022-02-16

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