# FDA 483 - Nukemed Inc - May 12, 2022

Source: https://www.keypedia.com/records/483/nukemed-inc/e9e5f603-1a27-4b91-8ba9-90b4bb24c634

> FDA 483 for Nukemed Inc on May 12, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nukemed Inc
- Inspection Date: 2022-05-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Nukemed dba Spectron Rx, LLC, a sterile radiologic drug manufacturer in South Bend, IN, was cited for significant deficiencies in its aseptic processing areas. Observations included inadequate environmental monitoring systems, lack of procedures for critical air pattern analysis parameters, and unscientific aseptic personnel practices for inspecting media-filled units. These issues indicate a high risk of microbiological contamination in sterile drug products.

## Related Officers

- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/nukemed-inc/7fd46c6b-8d23-4f41-9732-bd662d9be320

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0