483
LTS Lohmann Therapy Systems CorpLTS Lohmann Therapy Systems Corp – FDA 483, Jun 11, 2019
Record Details
During an inspection, LTS Lohmann Therapy Systems Corp in West Caldwell, NJ, was cited for significant deficiencies in their quality system and laboratory controls. The firm failed to thoroughly investigate out-of-specification results and lacked statistical justification for batch release. Additionally, inadequate controls over computer systems, including disabled audit trails and unauthorized access, compromised data integrity.
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ID · ff75b45e-6d62-4a59-92eb-85630330b407
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