# FDA 483 - Sina Health Inc - January 13, 2023

Source: https://www.globalkeysolutions.net/records/483/sina-health-inc/b7f28222-33de-47ce-8f8f-4b17f7c54358

> FDA 483 for Sina Health Inc on January 13, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sina Health Inc
- Inspection Date: 2023-01-13
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Sina Health Inc., a repacker in Scottsdale, AZ, received a Form FDA 483 with four observations during an inspection from January 9-13, 2023. The inspection revealed significant deficiencies including the quality control unit's failure to approve written procedures, a lack of annual batch record evaluations, inadequate labeling control, and the absence of equipment calibration procedures. These findings indicate a general lack of adherence to established quality systems and good manufacturing practices.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)

Company: https://www.globalkeysolutions.net/companies/sina-health-inc/c6dc4fe1-9011-4a84-8d9d-66fa4f6c482b

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face