# FDA 483 - Corium Innovations, Inc. - October 27, 2017

Source: https://www.keypedia.com/records/483/corium-innovations-inc/38aa6ddb-cc6b-464c-9362-b118217b295d

> FDA 483 for Corium Innovations, Inc. on October 27, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corium Innovations, Inc.
- Inspection Date: 2017-10-27
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Corium International, Inc. in Grand Rapids, MI, revealed significant deficiencies in quality control and manufacturing processes. Observations included failures to thoroughly investigate product discrepancies and patient complaints, inadequate laboratory controls for product release specifications, and a lack of validated control procedures for manufacturing processes. These issues indicate a moderate level of non-compliance with good manufacturing practices.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)
- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)
- [Caroline Strainger](https://www.keypedia.com/people/caroline-strainger/ee8116d2-3bde-4360-acc1-602dd614a0f4)

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