# FDA 483 - LTS Therapy Systems, LLC - September 30, 2025

Source: https://www.keypedia.com/records/483/lts-therapy-systems-llc/37b54d1f-ed22-42ec-a7d6-ad9fa71abc23

> FDA 483 for LTS Therapy Systems, LLC on September 30, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: LTS Therapy Systems, LLC
- Inspection Date: 2025-09-30
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of LTS Therapy Systems LLC in Saint Paul, MN, a drug manufacturer, revealed significant deficiencies across multiple quality system areas. The firm failed to thoroughly investigate manufacturing discrepancies, maintain adequate laboratory controls including data integrity, and establish sound production and process control procedures. Additionally, the quality control unit's responsibilities and procedures were found to be inadequate, indicating a broad lack of adherence to cGMP requirements.

## Related Documents

- [483 - 2019-01-31](https://www.keypedia.com/records/483/lts-therapy-systems-llc/50020131-5c36-4231-8ee8-f4b12932e89e)

## Related Officers

- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)
- [Soyinka S. Eneng](https://www.keypedia.com/people/soyinka-s-eneng/a7f69c63-1beb-4c59-9ccd-6e35c49a10c5)

Company: https://www.keypedia.com/companies/lts-therapy-systems-llc/2bbbf391-d6c1-4789-a5da-63a32fda9b30

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d