# FDA 483 - ASEPTIKITS, LLC - December 03, 2025

Source: https://www.keypedia.com/records/483/aseptikits-llc/52adf05d-a2c9-4106-b0fa-ab739b2bdc03

> FDA 483 for ASEPTIKITS, LLC on December 03, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ASEPTIKITS, LLC
- Inspection Date: 2025-12-03
- Product Type: device
- Office Name: FDA District Office — Denver, Colorado
- Summary: ASEPTIKITS, LLC, a specification developer in North Salt Lake, UT, was cited for multiple significant quality system deficiencies during an FDA inspection. The firm lacks fundamental procedures for design control, device master records, purchasing controls, finished device acceptance, management review, and internal quality audits. Additionally, the firm failed to submit required UDI information to the FDA's GUDID for its medical devices.

## Related Documents

- [WARNING_LETTER - 2025-12-03](https://www.keypedia.com/records/warning_letter/aseptikits-llc/2a03bee3-0d9c-4fbf-b9f7-af4988c16aaa)

## Related Officers

- [Monica L. Gutierrez](https://www.keypedia.com/people/monica-l-gutierrez/fe60f8c6-ad1b-4619-9903-ed7be6d3bf7d)
- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/aseptikits-llc/3d3b1df5-4125-46b6-bacb-d99ea76fcedd

Office: https://www.keypedia.com/offices/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0