# FDA 483 - TRUECARE BIOMEDIX - February 21, 2025

Source: https://www.globalkeysolutions.net/records/483/truecare-biomedix/82bded1b-736e-4b5c-8008-e3028c9d0450

> FDA 483 for TRUECARE BIOMEDIX on February 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TRUECARE BIOMEDIX
- Inspection Date: 2025-02-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of TrueCare Biomedix in Kalishore, India, revealed a significant issue with the firm's quality control unit. Specifically, the company's written procedures for good documentation practices were not consistently followed, leading to a lack of required signatures and dates in log books. This indicates a moderate severity concern regarding adherence to established quality control protocols.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/chad-w-rice/b00f381a-744d-4e5e-90bf-07f60f494afc)

Company: https://www.globalkeysolutions.net/companies/truecare-biomedix/08911ceb-dc17-46dc-bab8-b43b871cc64c

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8