# Boehringer Laboratories, Inc. – FDA 483, Jun 24, 2026

Source: https://www.keypedia.com/records/483/boehringer-laboratories-inc/ab51cf7c-2456-48ee-a61c-2c1de4c806b7

> FDA 483 for Boehringer Laboratories, Inc. on June 24, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boehringer Laboratories, Inc.
- Inspection Date: 2026-06-24
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Boehringer Laboratories, Inc. in Phoenixville, PA, revealed significant deficiencies in the manufacturing and design controls for their new VISIGI® LUX medical device. The firm failed to adequately document process validation and maintain a complete design and development file, leading to issues like unverified design inputs and customer complaints. These observations indicate serious non-compliance with quality system regulations.

## Related Officers

- [Nadia R. Barreda](https://www.keypedia.com/people/nadia-r-barreda/ef624359-957a-45e4-89c9-5b5ff215c6aa)

Company: https://www.keypedia.com/companies/boehringer-laboratories-inc/7c3da463-ea98-4e9a-92cf-31a702872932

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8