# FDA 483 - Dermolab Pharma Ltd. - October 13, 2023

Source: https://www.keypedia.com/records/483/dermolab-pharma-ltd/f18d70e7-429c-48b4-bc43-f6b465643448

> FDA 483 for Dermolab Pharma Ltd. on October 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dermolab Pharma Ltd.
- Inspection Date: 2023-10-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Dermolab Pharma Ltd. in Sainte-Julie was inspected and cited for significant deficiencies in its quality control and manufacturing processes for OTC drug products. Observations included a lack of validated manufacturing processes, inadequate investigation of microbial excursions, insufficient raw material testing, and the absence of annual product reviews. These issues indicate a severe lack of control over product quality and compliance.

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.keypedia.com/companies/dermolab-pharma-ltd/7225f963-3084-4281-b5da-e046668f2136

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