# FDA 483 - PAVmed Inc. - April 15, 2022

Source: https://www.keypedia.com/records/483/pavmed-inc/f4d954eb-8ac4-44a2-ad82-d7f8a513227b

> FDA 483 for PAVmed Inc. on April 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PAVmed Inc.
- Inspection Date: 2022-04-15
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of PAVmed Inc., a medical device manufacturer in Foxborough, MA, identified two observations. The firm was cited for inadequate procedures for receiving, reviewing, and evaluating complaints, specifically regarding the investigation of complaint #21001. Additionally, corrective and preventive action activities and their results, including effectiveness checks for CAPA# 2020-002, were not adequately documented.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/pavmed-inc/24ac6406-3a0e-42a7-84b2-3b856a7c1b26

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94