# FDA 483 - Derma Care Research Labs LLC - September 24, 2019

Source: https://www.globalkeysolutions.net/records/483/derma-care-research-labs-llc/459eef12-6787-40eb-8c15-824a48302116

> FDA 483 for Derma Care Research Labs LLC on September 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Derma Care Research Labs LLC
- Inspection Date: 2019-09-24
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Perrigo Care Research Laboratories, LLC, a topical OTC drug manufacturer in Daytona Beach, FL, was cited for significant deficiencies during an FDA inspection. Observations included the release of drug products made with out-of-specification water, inadequate data integrity controls, and a lack of essential laboratory and process validations. The firm also failed to demonstrate effective cleaning processes for equipment and proper equipment qualification.

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## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.globalkeysolutions.net/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.globalkeysolutions.net/companies/derma-care-research-labs-llc/37802e66-846a-4e2c-8270-ed9dbbceca20

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6