# FDA 483 - LTS Lohmann Therapy Systems Corp - June 11, 2019

Source: https://www.keypedia.com/records/483/lts-lohmann-therapy-systems-corp/ff75b45e-6d62-4a59-92eb-85630330b407

> FDA 483 for LTS Lohmann Therapy Systems Corp on June 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LTS Lohmann Therapy Systems Corp
- Inspection Date: 2019-06-11
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)
- [Compliance Officer at FDA](https://www.keypedia.com/people/emmanuel-j-ramos/ba0666bd-2752-453e-9fd3-5e43b1cff3ad)

Company: https://www.keypedia.com/companies/lts-lohmann-therapy-systems-corp/8f67161c-919b-4a64-9e2e-4cc4b5ea9e52

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248