# FDA 483 - DermaPharm A/S - September 19, 2019

Source: https://www.keypedia.com/records/483/dermapharm-as/d8d2358f-5417-45d0-af6d-7b7bb77431e3

> FDA 483 for DermaPharm A/S on September 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DermaPharm A/S
- Inspection Date: 2019-09-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: DermaPharm A/S, an OTC drug product manufacturer in Farup, Denmark, was cited for three observations during an FDA inspection. The observations primarily concern deficiencies in laboratory controls, including inadequate testing of finished drug products for potency and microbial contamination, a lack of established specifications for drug products and raw materials, and the absence of written procedures for investigating unexpected laboratory results.

## Related Documents

- [WARNING_LETTER - 2019-09-19](https://www.keypedia.com/records/warning_letter/dermapharm-as/eba369f7-c9d0-4248-a2eb-f86aed45f740)

## Related Officers

- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.keypedia.com/companies/dermapharm-as/6bea9859-5e4e-4d9d-a74c-14600a77cf0f

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1