# FDA 483 - Radienz Living LLC - January 11, 2024

Source: https://www.keypedia.com/records/483/radienz-living-llc/4908cf82-4e17-4ab4-a625-ed021d6ba217

> FDA 483 for Radienz Living LLC on January 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Radienz Living LLC
- Inspection Date: 2024-01-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Radienz Living LLC in Commack, NY, was cited with six observations during an FDA inspection concerning its manufacturing of Hemorrhoidal Pads. The firm failed to validate manufacturing processes and cleaning procedures, and lacked proper controls over computerized laboratory systems, allowing data alteration. Additionally, equipment was not qualified, storage conditions were unmonitored, and batch records were incomplete.

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)
- [Pharmacist | Consumer Safety Officer](https://www.keypedia.com/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

Company: https://www.keypedia.com/companies/radienz-living-llc/eb0c62f0-67bb-4fab-a929-74e29b70427e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961