# FDA 483 - Infrared Laboratories, LLC - April 01, 2024

Source: https://www.keypedia.com/records/483/infrared-laboratories-llc/36f5f6a4-1e05-4b5b-a2ce-3a83f1398f29

> FDA 483 for Infrared Laboratories, LLC on April 01, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Infrared Laboratories, LLC
- Inspection Date: 2024-04-01
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Infrared Laboratories, LLC in Westfield, IN, was inspected by the FDA from March 25 to April 1, 2024. The inspection revealed a significant deficiency in the firm's design control procedures, specifically concerning the establishment and documentation of design outputs. This indicates a failure to adequately define and verify product design, which is a critical aspect of quality system compliance for manufacturers.

## Related Officers

- [Melina L. Rodriguez-Upton](https://www.keypedia.com/people/melina-l-rodriguez-upton/0b540980-5708-4251-8ea6-6254375506f1)

Company: https://www.keypedia.com/companies/infrared-laboratories-llc/17d6bb83-dbc6-40f5-93dc-b80f0286f9ba

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0