# FDA 483 - LTS Therapy Systems, LLC - January 31, 2019

Source: https://www.globalkeysolutions.net/records/483/lts-therapy-systems-llc/50020131-5c36-4231-8ee8-f4b12932e89e

> FDA 483 for LTS Therapy Systems, LLC on January 31, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LTS Therapy Systems, LLC
- Inspection Date: 2019-01-31
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Tapemark Company, a drug manufacturer in Saint Paul, MN, was cited for significant deficiencies in its quality control unit during an FDA inspection. Observations included failures to adhere to procedures for Corrective and Preventive Actions (CAPA) and Non-Conformance Management (NCM), as well as an inadequate product recall procedure. These issues indicate a lack of adherence to established quality system requirements.

## Related Documents

- [483 - 2025-09-30](https://www.globalkeysolutions.net/records/483/lts-therapy-systems-llc/37b54d1f-ed22-42ec-a7d6-ad9fa71abc23)

## Related Officers

- [Courtney R. Ingalsbe](https://www.globalkeysolutions.net/people/courtney-r-ingalsbe/534b281d-a2bf-473c-b17a-dc1ff42147df)
- [Deputy Commissioner for Foods](https://www.globalkeysolutions.net/people/james-k-ireland/78658286-3e62-4069-a8e1-b157aa77c7fe)

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

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