# FDA 483 - SmartScience Laboratories, Inc. - November 22, 2024

Source: https://www.keypedia.com/records/483/smartscience-laboratories-inc/1b5add14-e4cf-4622-a550-fe0d39cc177a

> FDA 483 for SmartScience Laboratories, Inc. on November 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SmartScience Laboratories, Inc.
- Inspection Date: 2024-11-22
- Product Type: drugs
- Office Name: Florida District Office
- Summary: SmartScience Laboratories, Inc. in Tampa, FL, a pharmaceutical contract manufacturer/repacker, was cited for numerous significant deficiencies during an FDA inspection from 11/18/2024 to 11/22/2024. The observations highlight severe issues across data integrity, quality control oversight, personnel qualification, manufacturing processes, laboratory controls, stability testing, and facility sanitation. These findings indicate a widespread lack of control and adherence to cGMP regulations, posing potential risks to drug product quality and patient safety.

## Related Documents

- [483 - 2018-12-10](https://www.keypedia.com/records/483/smartscience-laboratories-inc/2b3d90fe-a8d7-44ab-9a03-d8cc7a18b5a5)

## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)

Company: https://www.keypedia.com/companies/smartscience-laboratories-inc/a9541552-4e3a-4ad6-83e2-31a4fe4c8c39

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9