# FDA 483 - InVitroCare, Inc - August 03, 2023

Source: https://www.keypedia.com/records/483/invitrocare-inc/55959c0c-bc8d-4824-b9ad-3c1dd2737eb4

> FDA 483 for InVitroCare, Inc on August 03, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InVitroCare, Inc
- Inspection Date: 2023-08-03
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: InVitroCare, Inc. in Frederick, MD, was cited for significant deficiencies across its quality system during an FDA inspection. The firm lacked established procedures for design control, software validation, purchasing controls for suppliers, and numerous other critical quality system elements including nonconformance, CAPA, training, calibration, management review, and quality audits. These widespread issues indicate a fundamental failure to implement and maintain a compliant quality system for medical device manufacturing.

## Related Officers

- [Christina D. Mello](https://www.keypedia.com/people/christina-d-mello/b523622e-d2dd-4ff6-9b2b-74b3134841de)
- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/invitrocare-inc/55a32e03-0d2e-42fc-9c82-ff2ce97b2d33

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64