# OndaMed Inc – FDA Inspection, Sep 28, 2018

Source: https://www.keypedia.com/records/fda_inspections/ondamed-inc/a9c51805-ec82-4916-abaf-df1b4f7966b2
Source feed: FDA_Inspections

> FDA inspection 1067339 of OndaMed Inc, September 28, 2018. Classification: Voluntary Action Indicated (VAI). 4 citations under 21 CFR parts 803 and 820. Form 483 issued. 2 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1067339
- Company Name: OndaMed Inc
- Inspection Date: 2018-09-28
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Postmarket Assurance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 4

## Related Documents

- [FDA Inspection 986755 - 2016-08-15](https://www.keypedia.com/records/fda_inspections/ondamed-inc/10f3baf8-1177-4a70-91e2-a5966d5221ff)
- FDA Inspection 938468 - 2015-08-17

## Related Officers

- [Issuing Officer](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/ondamed-inc/fe0ea238-d61c-4acd-b986-5a9da81bd84c

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7