# FDA 483 - ATLAS R&D Inc - September 06, 2018

Source: https://www.globalkeysolutions.net/records/483/atlas-rd-inc/7961d192-7294-43a6-b85d-51c3255ee3ae

> FDA 483 for ATLAS R&D Inc on September 06, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ATLAS R&D Inc
- Inspection Date: 2018-09-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: ATLAS R&D Inc, an OTC drug manufacturer in Cambridge, was inspected by the FDA. The inspection revealed significant deficiencies across multiple areas of their manufacturing and quality control processes, including lack of stability testing, inadequate microbial testing validation, insufficient raw material identity testing, and poor documentation of manufacturing steps and annual product reviews. These issues indicate a lack of robust quality systems for drug product manufacturing.

## Related Documents

- [483 - 2018-09-06](https://www.globalkeysolutions.net/records/483/atlas-rd-inc/b51ef5f7-6125-4dd1-a290-a64d19cd430c)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/atlas-rd-inc/24da3f00-c4f9-413f-8a82-2e967d78dcd4

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1