# FDA 483 - Morton Grove Pharmaceuticals, Inc. - May 20, 2021

Source: https://www.keypedia.com/records/483/morton-grove-pharmaceuticals-inc/3f140cbe-6ae7-48ed-b236-2ea6e440f50e

> FDA 483 for Morton Grove Pharmaceuticals, Inc. on May 20, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Morton Grove Pharmaceuticals, Inc.
- Inspection Date: 2021-05-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Morton Grove Pharmaceuticals, Inc. received a Form 483 citing significant deficiencies across its quality system. Issues include inadequate investigations into recurring microbial contamination and out-of-specification results, widespread data integrity concerns in the QC laboratory, and failures in stability testing and cleaning validation. These findings indicate a lack of robust controls to ensure drug product quality and purity.

## Related Documents

- [483 - 2014-03-26](https://www.keypedia.com/records/483/morton-grove-pharmaceuticals-inc/c98ba2bb-0960-4258-91d8-955fb35acd68)
- [483 - Unknown Date](https://www.keypedia.com/records/483/morton-grove-pharmaceuticals-inc/0fbea83f-1f82-4087-a896-461d44ec0c82)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Albin Varghese](https://www.keypedia.com/people/albin-varghese/adb6a0a4-fd6d-49ae-bd3f-2b893a7b8278)
- [Investigator](https://www.keypedia.com/people/sarah-e-rhoades/d965990c-15cc-4722-b2d0-aea7206c71b0)

Company: https://www.keypedia.com/companies/morton-grove-pharmaceuticals-inc/af69e5a6-adb6-438f-9bd4-79ab8f823315

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0