US FDA warns Korean & Chinese firms for cGMP violations

Firson’s warning letter​ references an FDA site visit in November last year.

According to the Administration, the finished formulation site – located in Seobuk-gu, South Korea – violated current good manufacturing practice (cGMP) in a number of areas, including failing to implement anti-microbiological contamination procedures.

“Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterialisation processes,” ​the letter said.

Further, the FDA said the Firson failed to establish laboratory controls to assure drug products conform to appropriate standards of identity, strength, quality and purity, and requested the company complete retroactive testing of potentially compromised batches.

“Respond promptly with all results. If your data indicates that defective products are in the US marketplace, commit to recall the products,” ​the FDA instructed.

The FDA’s warning letter​ to Chinese firm Wuxi Medical Instrument Factory similarly cited cGMP violations including failure to sanitize equipment and to provide written records of equipment maintenance.

“On March 7, 2017, our investigator observed that your firm had stored clean…tubing ​[used to transfer drug products] in an open container in your Apparatus Storage Room. The exposed tubing ends were not covered to protect against dust or other contamination of your terminally sterilized drug product.”​

“You lacked procedures for maintaining, cleaning, and sanitizing this tubing to prevent contamination,” ​said the letter.

The Administration has advised both firms to involve a cGMP consultant to attain manufacturing practice requirements.