# FDA 483 - Nomax Inc - December 02, 2022

Source: https://www.keypedia.com/records/483/nomax-inc/de5c4f0a-98b8-443a-8ec6-d20401f7ffb5

> FDA 483 for Nomax Inc on December 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nomax Inc
- Inspection Date: 2022-12-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Novus, Inc., a sterile drug manufacturer in Saint Louis, MO, was cited for significant deficiencies across its quality system, laboratory controls, and manufacturing processes. Observations included failures to investigate critical incidents, inadequate data integrity and testing procedures, and a lack of proper quality unit oversight. These findings indicate a systemic breakdown in GMP compliance impacting the quality and sterility assurance of its ophthalmic strips and potassium bicarbonate tablets.

## Related Documents

- [WARNING_LETTER - 2016-10-27](https://www.keypedia.com/records/warning_letter/nomax-inc/79e9daea-cca5-4615-8ae9-1abad26ab361)
- [EIR - 2018-02-01](https://www.keypedia.com/records/eir/nomax-inc/19e7ce70-e68b-4393-add1-72957061c091)
- [483 - 2018-02-01](https://www.keypedia.com/records/483/nomax-inc/f9b1be40-af0b-4f69-ae37-dc2c793bcebb)

## Related Officers

- [Consumer Safety Officer, FDA](https://www.keypedia.com/people/conner-n-mann/626fec03-b389-435c-b038-376fcc0952ac)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/nomax-inc/269d696c-bdf9-48a2-9ce3-2ba71aef35aa

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8