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.
The firm did not validate processes used to manufacture OTC products, neglecting to perform process qualification studies and lacking an ongoing program to monitor process control and ensure stable manufacturing operations and drug quality.
The firm also failed to test all incoming active pharmaceutical ingredients and components for quality, purity, strength and identity before using them in the drug manufacturing process.
In addition, the firm’s stability data did not support the assigned product expiration dates. The facility failed to sufficiently assess the products’ stability characteristics.
The firm also produced misbranded products, as their labels failed to declare the active ingredients and proportions. It also used active ingredients in the products that were not declared on the label.
The facility could not provide a list of all inactive ingredients contained in the products and acknowledged that not all inactive ingredients were declared on the labels.