When it comes to making eye drops, one Chinese manufacturer failed to clearly see the rules for sterile manufacturing, according to the U.S. Food and Drug Administration.
Hubei Kangzheng was admonished by the regulator for a host of production lapses that could have led to microbial contamination in its Pi Yen Chin drops, according to a Nov. 23, 2021, warning letter that was posted on the agency web site this week.
A key issue was that the company also made non-sterile nasal drops and wrongfully believed its manufacturing standards did not need to comply with procedures for sterile ophthalmic drops, which are sold over-the-counter. The FDA referred to this argument as a “misguided notion.”
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