> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# QS Violations at Ming Fai Industrial
- URL: https://www.fdaweb.com/qs-violations-at-ming-fai-industrial/
- Published: 2023-11-14T12:00:00.000Z
- Updated: 2026-09-14T14:16:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155781

A 3/6-3/10 FDA inspection at Ming Fai Industrial Co in Guangdong Sheng, China, found Quality System regulation violations in the firm’s manufacturing of ultrasound gel and probe cover products. A just-released 6/1 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ming-fai-industrial-co-ltd-660075-06012023?ref=fdaweb.com) says the specific violations were:

- failing to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure; and
- failing to identify by suitable means the acceptance status of the product, to indicate the conformance or nonconformance of product with acceptance criteria.

Ming Fai was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.