# FDA 483 - Apex Healthcare Limited - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/apex-healthcare-limited/0c59f5c2-c52b-4549-acc5-5d6bc3e38d85

> FDA 483 for Apex Healthcare Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apex Healthcare Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection from June 12-15, 2023, Apex Healthcare Limited in Ankleshwar, Gujarat, India, was cited for significant deficiencies in their quality control and data integrity practices. Observations included inadequate procedures for reviewing laboratory control records and audit trail error messages, insufficient controls to prevent data loss in computerized systems, and the absence of a label reconciliation procedure for finished API batches. These issues indicate a lack of robust controls over critical manufacturing and testing data.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/apex-healthcare-limited/77487c03-dfcf-4cd2-82fc-bc9d143eea28

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