# FDA 483 - VitaCare Labs Inc. - May 16, 2025

Source: https://www.keypedia.com/records/483/vitacare-labs-inc/73895344-3a49-4cf9-a058-c6acbb021f43

> FDA 483 for VitaCare Labs Inc. on May 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VitaCare Labs Inc.
- Inspection Date: 2025-05-16
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: VitaCare Labs Inc., an OTC drug manufacturer in Mississauga, was inspected by the FDA and received a Form 483 with six observations, many of which were repeats from a previous inspection in 2018. The inspection revealed significant deficiencies across production, quality, and laboratory control systems, including inadequate process and cleaning validations, poor equipment maintenance, incomplete batch records, failure to follow stability testing programs, insufficient component testing, and inadequate investigations into microbial contamination. These issues indicate a systemic failure to ensure drug product quality, purity, and strength.

## Related Officers

- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)

Company: https://www.keypedia.com/companies/vitacare-labs-inc/d753677c-a202-4dff-b770-ddc92b810e37

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3