# FDA 483 - NorMed - May 29, 2025

Source: https://www.keypedia.com/records/483/normed/dbdc1276-6942-4a69-9b02-33b7603df1b9

> FDA 483 for NorMed on May 29, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NorMed
- Inspection Date: 2025-05-29
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: NorMed, a drug repacker in Tukwila, WA, received a Form FDA 483 with two repeat observations during an inspection. The firm failed to validate the reliability of component supplier analyses for its own-label OTC drug products. Additionally, drug products were not stored under appropriate temperature and humidity conditions, and environmental monitoring and device calibration were found to be inadequate.

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [FDA_PERSONNEL](https://www.keypedia.com/people/aranjeet-singh/7359f43e-0e36-4cdd-a77d-3371d8b44b99)
- [Thuy Tram L. Nguyen](https://www.keypedia.com/people/thuy-tram-l-nguyen/b58f2445-728e-4f79-b7eb-4dfb7e982e25)

Company: https://www.keypedia.com/companies/normed/2e84bcd7-5385-402f-aa98-f9cd6ef65f5b

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913