Millar LLCJuly 1, 2025

FDA 483 - Millar LLC - July 01, 2025

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Record Details

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.

Company: Millar LLC
Inspection Date: July 1, 2025
Product Type: Device
Office: Division of Human and Animal Food Operations - West III
Person: Ellen J. Tave

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ID · d6e7816b-9565-4c9a-b222-ba1ba3de9347