# FDA 483 - Corium Innovations, Inc. - November 18, 2022

Source: https://www.keypedia.com/records/483/corium-innovations-inc/408927fd-60f9-44b0-86d7-812a898cda17

> FDA 483 for Corium Innovations, Inc. on November 18, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corium Innovations, Inc.
- Inspection Date: 2022-11-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Corium Pharma Solutions, Inc. in Grand Rapids, MI, was inspected and cited for significant deficiencies in its manufacturing process controls, quality unit procedures, and facility sanitation. The inspection revealed inadequate process validation for Donepezil Transdermal Delivery System, failures in following written procedures for material disposition and document control, and unsanitary conditions due to lacking cleaning procedures. These issues indicate a lack of robust quality oversight and control over critical manufacturing and facility maintenance operations.

## Related Documents

- [483 - 2017-10-27](https://www.keypedia.com/records/483/corium-innovations-inc/38aa6ddb-cc6b-464c-9362-b118217b295d)
- [483 - 2019-09-16](https://www.keypedia.com/records/483/corium-innovations-inc/0f09f475-4681-42cd-ab32-27eb150a281d)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Brent M. Dehaan](https://www.keypedia.com/people/brent-m-dehaan/7a6af4a2-2566-48af-b59d-dd59008ff997)
- [investigator](https://www.keypedia.com/people/amanda-m-dunneback/ee8334d4-88ab-4c52-b34b-1286a0066609)

Company: https://www.keypedia.com/companies/corium-innovations-inc/6ef69358-81bb-44a9-a576-41a1c5d94783

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