# FDA 483 - Morton Grove Pharmaceuticals, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/morton-grove-pharmaceuticals-inc/0fbea83f-1f82-4087-a896-461d44ec0c82

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

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## Details

- Record Type: 483
- Company Name: Morton Grove Pharmaceuticals, Inc.
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Morton Grove Pharmaceuticals received a Form 483 detailing significant deficiencies across its quality control unit, laboratory operations, and manufacturing processes. The inspection revealed issues including data integrity concerns, inadequate investigations into discrepancies, and failures in equipment maintenance and environmental controls. These findings indicate a lack of adherence to cGMP requirements, potentially impacting the quality and purity of distributed drug products.

## Related Documents

- [483 - 2014-03-26](https://www.keypedia.com/records/483/morton-grove-pharmaceuticals-inc/c98ba2bb-0960-4258-91d8-955fb35acd68)
- [483 - 2021-05-20](https://www.keypedia.com/records/483/morton-grove-pharmaceuticals-inc/3f140cbe-6ae7-48ed-b236-2ea6e440f50e)

## Related Officers

- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)
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- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

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

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669