# FDA 483 - Millar LLC - July 01, 2025

Source: https://www.globalkeysolutions.net/records/483/millar-llc/d6e7816b-9565-4c9a-b222-ba1ba3de9347

> FDA 483 for Millar LLC on July 01, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Millar LLC
- Inspection Date: 2025-07-01
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Millar LLC, a medical device manufacturer in Houston, TX, received a Form 483 citing multiple quality system deficiencies. The firm failed to conduct annual internal quality management system audits and demonstrated inadequate procedures for receiving, reviewing, and evaluating complaints. Additionally, issues were noted with inconsistent sampling plans for incoming product acceptance and undocumented equipment checks and maintenance activities.

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/millar-llc/6dd119e4-d6f9-47d5-9d5e-b84eee50e357

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab