483
Millar LLCFDA 483 - Millar LLC - July 01, 2025
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.
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ID · d6e7816b-9565-4c9a-b222-ba1ba3de9347