FDA slaps Chinese manufacturer in warning letter for obstructing inspection

Zhejiang Bangli Medical Products was cited in an FDA warning letter for limiting an inspection. Image: Bangli

Zhejiang Bangli Medical Products, a medical dressing manufacturer in China, received a warning letter for limiting an FDA inspection last year, among other breaches of regulations.

According to a warning letter the agency sent to the company dated Jan. 26, 2017, Bangli limited FDA’s inspection in the sense that it “refused to provide FDA with records related to suppliers of components and products that you repackage at your facility.”

Even though the company did provide names of two of its suppliers, it refused to provide documentation to show what exactly it had obtained from those suppliers, or whether they had performed appropriate testing on the materials when releasing them to Bangli, the letter said.

The agency also uncovered a series of other cGMP regulations violations, some of which could potentially pose serious dangers to patients since many products the company produced should be strictly aseptic for surgical uses and wound care.

The firm, as the agency observed, failed to test each batch of products, test samples of each component to determine their purity and quality, and clean and maintain its equipment under written procedures, which themselves were not even established.

During a two-day inspection last August, investigators noticed rust and unidentified residue on several pieces of its manufacturing equipment. The investigator also observed that employees at the facility leave unlabeled medical patches of different sizes randomly on a table before final packaging, which the agency said could lead to product mix-ups.

According to its website, Zhejiang Bangli Medical Products, located in Zhejiang Province of China, is focused on foreign markets. Its products include first-aid kits, surgical plasters, wound dressing pad and nasal strips, among others. Its annual sales have reached around 120 million Chinese yuan ($18 million) and is growing steadily at about 40% every year.

However, the firm could take a hit since the FDA has placed it on two import alerts starting from last September, and if the company fails to correct those violations, the FDA may continue to refuse admission of its products.

Simply refusing an FDA inspection is enough for the agency to issue a warning letter, and other companies have been penalized for doing just that. Last year, the agency slapped Japanese drug manufacturer Nippon Fine Chemical with a warning letter for obstructing an inspection at its plant the year before.

Not only were investigators limited in their access to the facility located in Takasago City, at one point an NFC manager directed employees to form a human barrier by standing shoulder to shoulder to block access to areas of the laboratory and equipment used to analyze drugs destined for U.S. distribution.