Chinese Devicemaker Health Line Gets 483 for CAPA, DHR Problems

Health Line International, a Chinese devicemaker, received an FDA Form 483 for delaying effectiveness checks on CAPAs and other quality issues.

Eight out of the nine CAPAs reviewed by the FDA investigator only had effectiveness checks after the date of CAPA closure, according to the Jan. 9 form, which was recently released. The company’s CAPA procedures don’t discuss verification or validation of the activities, the form adds. They also don’t specify that data on quality problems should be shared with those responsible for product quality. Neither procedure discusses management review of such information.

The Form 483 followed a Jan. 6-9 inspection of Health Line’s Foshan, China, manufacturing facility.

The FDA investigator also looked at Health Line’s completed customer complaint forms and found they lacked addresses or records of replies. Complaints are classified by importance, but the records don’t specify who will evaluate the complaints for FDA reportability, the form says.

Additional observations relate to device history records. A review of six device history records showed that each included a copy of the product label but did not have a signed and dated record of examination and release. During the inspection, Health Line produced a copy of a form where it records label information. “However, I did not see that any record of this information was included in each DHR,” the investigator notes.

Meanwhile, the DHRs also failed to identify equipment used for measurements during final acceptance testing.

The investigator further found that Health Line’s nonconforming product procedure doesn’t require the documentation of rework and reevaluation activities in DHRs.

Health Line said it “immediately corrected” the observations and its corrective actions have been verified as effective. “The observations listed had no impact on product released to the field,” the company added.

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