# FDA WARNING_LETTER - Xoran Technologies Inc - October 26, 2007

Source: https://www.globalkeysolutions.net/records/warning_letter/xoran-technologies-inc/30c3deea-2685-44a2-a19e-d7f28540e823

> FDA WARNING_LETTER for Xoran Technologies Inc on October 26, 2007. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Xoran Technologies Inc
- Inspection Date: 2007-10-26
- Product Type: Devices
- Office Name: Detroit District Office
- Summary: On March 25, 2008, the FDA issued a Warning Letter to Xoran Technologies, Inc. following an inspection from August 30, 2007, to October 26, 2007. The inspection found that the firm's MiniCAT CT System, a medical device, was adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation (21 CFR Part 820).

Violations included:
1.  Failure to document design validation results in Design History Files (21 CFR § 820.30(g)).
2.  Failure to maintain a complete Device Master Record (21 CFR § 820.181).
3.  Failure to document proper installation procedures and results (21 CFR § 820.170(b)).
4.  Failure to maintain Device History Records with primary identification labels (21 CFR § 820.184(e)).
5.  Failure to control document approval and distribution (21 CFR § 820.40(a)).
6.  Failure to validate and document computer software used in production or the quality system (21 CFR § 820.70(i)).

## Related Officers

- [Ms.](https://www.globalkeysolutions.net/people/joanne-m-givens/7d6d17bd-5f41-4cdf-8f88-488b560f73f8)
- [Amy Kim](https://www.globalkeysolutions.net/people/amy-kim/eee8b97a-b9d0-4709-96dc-70dbadd3a6a4)

Company: https://www.globalkeysolutions.net/companies/xoran-technologies-inc/c2c366fe-f179-4e04-b3a1-ff14c9a879d4

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03