# FDA 483 - Massco Dental - September 02, 2022

Source: https://www.globalkeysolutions.net/records/483/massco-dental/808b833a-8975-40c4-87d7-c31a91f47b2d

> FDA 483 for Massco Dental on September 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Massco Dental
- Inspection Date: 2022-09-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Dunagin Pharmaceuticals, Inc. dba Massco Dental in Rogers, AR, was cited with seven observations during an FDA inspection. The firm demonstrated significant deficiencies across its manufacturing operations, including a lack of validation for its water system, manufacturing processes, and cleaning procedures. Additionally, the quality control unit was found to be inadequate, and there were issues with component testing, equipment maintenance, and laboratory investigations, indicating a systemic failure to ensure drug product quality and purity.

## Related Documents

- [483 - 2016-08-18](https://www.globalkeysolutions.net/records/483/massco-dental/4a230160-2766-4cc2-a1b3-28e7eab3c2fd)

## Related Officers

- [Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)

Company: https://www.globalkeysolutions.net/companies/massco-dental/ee29f974-dddf-4781-a394-c4622b74a26b

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab