# FDA 483 - Coloplast Corp - April 11, 2024

Source: https://www.keypedia.com/records/483/coloplast-corp/e97c16e6-72df-4a29-b416-f7562e784e36

> FDA 483 for Coloplast Corp on April 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Coloplast Corp
- Inspection Date: 2024-04-11
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Coloplast Manufacturing US, LLC in North Mankato, MN, a manufacturer of OTC drugs, was cited for three significant deficiencies during an FDA inspection. Observations included a lack of temperature mapping studies for drug product storage, absence of microbiological testing for Burkholderia Cepacia Complex in water used for non-sterile products, and inadequate written procedures for the site's Quality Unit responsibilities. These issues indicate potential risks to drug product quality and purity.

## Related Officers

- [Soyinka S. Eneng](https://www.keypedia.com/people/soyinka-s-eneng/a7f69c63-1beb-4c59-9ccd-6e35c49a10c5)

Company: https://www.keypedia.com/companies/coloplast-corp/c7749d8b-30c7-4836-9ff6-b933832244c3

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d