FDA Issues Warning Letter To South Korean Drug Manufacturer Over Sterility Concerns

A South Korean drug manufacturer has failed to take the proper precautions to prevent microbial contamination for products that are supposed to be sterile, according to a warning issued by federal drug regulators. 

The FDA issued a warning letter to Hanlim Pharm Co. earlier this month, indicating that an inspection revealed violations of current good manufacturing processes at its plant in Seocho-Dong, South Korea. The warning letter comes after the company’s products were placed on the FDA’s import ban list in May.

While the drugs are no longer banned, the warning letter indicates that the company’s manufacturing plant, which makes primarily sterile ophthalmic drugs, which are used to treat conditions affecting the eyes, failed inspection in a number of areas. The company makes a wide variety of other drugs, as well, including hypertension drugs like generic valsartan and olmesartan.

The FDA cited the plant’s “poor asceptic practices” during certain parts of its operation as posing a significant risk of microbial contamination. Inspectors saw operators touch drugs and products without disinfecting their hands, and saw them open bottles to clear bottle jams, leaning their heads and torsos over open bottles.

The inspectors also found that the plant lacked a system for monitoring environmental conditions in asceptic processing areas, failed to ensure lab records included complete data, and failed to ensure that only appropriate and authorized personnel had access to master production and control records.

The FDA is requiring the company to come up with detailed plans to address these problems, and a plan to ensure data integrity, saying it is aware a supervisor backdated records; putting earlier dates on documents than the actual date.

The agency warned that failure to address the problems could see Hanlim drug products again placed on the FDA import ban list.

Hanlin had 15 working days to respond to the letter, which was issued on October 3.

The issues come amid increasing concerns about byproducts of bad manufacturing practices, especially involving generic valsatan that may result in a cancer-causing impurity.

Worldwide valsartan recalls have been issued in recent months, after ingredients received from a Chinese manufacturer were found to be contaminated with N-nitrosodimethylamine (NDMA), a known human carcinogen that can result from poor manufacturing practices. As a result, the FDA has banned all products from that supplier, and faced increased scrutiny over regulation of foreign manufacturers.

Hanlin’s valsartan products were not among those recalled.