# FDA 483 - Capcium Inc. - April 08, 2022

Source: https://www.keypedia.com/records/483/capcium-inc/c67f7607-0979-4937-b88e-8ff73bc3282e

> FDA 483 for Capcium Inc. on April 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Capcium Inc.
- Inspection Date: 2022-04-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Capcium Inc., an OTC Drug Manufacturer in Pointe-Claire, was inspected by the FDA. The inspection revealed a significant issue related to the firm's failure to thoroughly investigate unexplained discrepancies, specifically an out-of-specification (OOS) result for a stability timepoint. This indicates a potential lack of robust quality control and adherence to established investigation procedures.

## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.keypedia.com/companies/capcium-inc/32d767ac-f991-4792-83e0-ed457d874800

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