Hong Kong Firm Draws Warning for Testing, Labeling Deficiencies

The FDA issued Nan San Pharmaceutical a warning letter for significant violations of CGMPs, including a failure to test product batches and inadequately labeling of product expiration dates.

During a September inspection at the firm’s Hong Kong facility, the inspector noted that the firm did not test all batches of over-the-counter topical liquid analgesics before batch release.

The firm performed microbial test limits for only one batch of its Easy-Flex analgesic lotion between 2013 and 2016, but reported the same results in order to release later batches to the U.S., the agency said.