483
Lohxa, LLCFDA 483 - Lohxa, LLC - July 19, 2021
Record Details
Lohxa, LLC, a drug repacker in Worcester, MA, received four observations during an FDA inspection, with three being repeat findings. The firm was cited for significant deficiencies including a lack of validated repacking processes, use of unqualified equipment, failure to conduct annual product reviews, and incomplete batch production records. These issues indicate a systemic lack of control over critical manufacturing and quality assurance operations.
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ID · 8b860e55-417b-4f7b-9d9c-d30c9fa7fd9c