# FDA 483 - Carma Laboratories, Inc. - November 14, 2023

Source: https://www.keypedia.com/records/483/carma-laboratories-inc/fd696db7-2ec5-41f1-90e5-0b5ff325d9a0

> FDA 483 for Carma Laboratories, Inc. on November 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carma Laboratories, Inc.
- Inspection Date: 2023-11-14
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Carma Laboratories, Inc. in Franklin, WI, a drug and cosmetic establishment, revealed significant deficiencies in quality control, training, facility sanitation, and data integrity. The firm failed to follow its own procedures for managing complaints, CAPAs, and nonconformances, and exhibited poor control over computer systems and document issuance. These issues indicate a lack of adherence to current Good Manufacturing Practices for their OTC lip balm and cold sore treatment products.

## Related Officers

- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

Company: https://www.keypedia.com/companies/carma-laboratories-inc/9687d675-9505-4431-b437-9daee7b74462

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