The company offers a range of products in the US that include a number of over-the-counter products, as well as sunscreens and skin whitening products.
FDA inspectors visited the Hanbul manufacturing facilities in Chuncheongbuk-do in November of last year and sent out the warning letter following the visit.
A follow up warning letter was then sent on March 30 of this year, which summarized that “significant violations of current good manufacturing practice" had still not been resolved.
FDA letter outlines four violation
The FDA letter listed four specific violations, while stressing that the issues its inspectors had identified were not necessarily limited to the outlined violations.
The first violation in the letter underscored that the company had failed to provide laboratory records with complete data for all the necessary tests required for compliance.
The next violation drew attention to the fact that the firm did not follow and adequate testing program to assess the stability characteristics of drug products to determine storage conditions and expiration dates.
Batch production and control records were also highlighted as being incomplete for the third violation, while the fourth and final violation stressed that equipment in the processing, packing and holding of the products failed to meet the adequate design requirements for its intended use, as well as cleaning and maintenance.
Previous action requests not heeded
The FDA also stated that previous requests that the company take corrective actions to the points it had raised immediately after its inspection at the end of the year had not been met with sufficient evidence that the issues had been resolved.
The letter went on to state that the organization strongly recommends that the firm engage a consultant to assist it in meeting the CGMP compliance necessary to resolve all the outstanding issues and that a third party should be employed to confirm that the issues are all resolved.
“You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations,” the letter stated.
The company has been placed on an FDA import alert since March 8, 2018.