Apnea Sciences CorporationAugust 19, 2021

FDA 483 - Apnea Sciences Corporation - August 19, 2021

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Apnea Sciences Corporation

Record Details

Apnea Sciences Corporation, a medical device manufacturer in Aliso Viejo, CA, was inspected by the FDA from August 16-19, 2021. The inspection revealed significant deficiencies in their quality system, specifically regarding corrective and preventive actions, device history records, and acceptance activities documentation. These issues indicate a lack of adherence to established procedures and regulatory requirements for medical device manufacturing.

Company: Apnea Sciences Corporation
Inspection Date: August 19, 2021
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
People: Alexandria L. Capuano (Investigator)
Kevin N. Tran

Open in Dashboard

ID · 1a1c176a-f651-429c-9b73-6f7420db3772