# FDA WARNING_LETTER - Moor Instruments Ltd - August 21, 2014

Source: https://www.globalkeysolutions.net/records/warning_letter/moor-instruments-ltd/8f844a83-8390-406c-aa13-4c7029524c59

> FDA WARNING_LETTER for Moor Instruments Ltd on August 21, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Moor Instruments Ltd
- Inspection Date: 2014-08-21
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On December 18, 2014, the FDA issued a Warning Letter to Moor Instruments Ltd. following an inspection from August 18-21, 2014, at their facility in Axminster, UK. The inspection revealed that their moorVMS-LDF and moorVMS-LDF-HP Laser Doppler Blood Flow Monitor devices are adulterated under section 501(h) of the Act, due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820).

The FDA identified six significant violations:
1.  Failure to establish and maintain adequate procedures for validating device design (21 CFR 820.30(g)), specifically regarding undocumented raw data and test results for moorVMS-LDF.
2.  Failure to establish and maintain adequate procedures for identification, documentation, validation/verification, review, and approval of design changes before implementation (21 CFR 820.30(i)). This included a lack of validation/verification requirements in procedures and for specific design changes (e.g., 1049, 1075, 798).
3.  Failure to establish and maintain rework procedures, including retesting and reevaluation of nonconforming product (21 CFR 820.90(b)(2)). Eight nonconformance records lacked documented retesting/

## Related Officers

- [President](https://www.globalkeysolutions.net/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.globalkeysolutions.net/companies/moor-instruments-ltd/f9ac536b-a7bb-4335-a899-bd10e9801b86

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7