QS Violations at Ming Fai Industrial
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 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.