# FDA 483 - Access Vascular, Inc. - October 06, 2022

Source: https://www.keypedia.com/records/483/access-vascular-inc/d1f98da1-d8c0-4b1a-a0e9-4ec7c116e1e2

> FDA 483 for Access Vascular, Inc. on October 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Access Vascular, Inc.
- Inspection Date: 2022-10-06
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Access Vascular, Inc. in Billerica, MA, revealed two significant observations. The firm failed to provide a documented statistical rationale for sampling plans for their Hydro MID Single Lumen Catheter and submitted Medical Device Reports (MDRs) for adverse events related to their Hydro-PICC Single Lumen Catheter beyond the required 30-day timeframe. These issues highlight deficiencies in quality system procedures and regulatory reporting compliance.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/access-vascular-inc/fd0e0fdb-a204-43be-a2ae-e01b8f22ba5f

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