The U.S. Food and Drug Administration (FDA) said it has pointed out 10 problems with Daewoong Pharmaceutical’s Botox plant, in a due diligence report Monday.

The factory, located in Osong, North Chungcheong Province, produces Nabota, the company’s botulinum toxin (BTX) type A product.

“Aseptic processing areas are deficient regarding the system for monitoring environmental conditions,” the FDA report said. “Specifically, there is no documentation to ensure that environmental monitoring (EM) samples are traceable and attributable, while EM samples are not handled in the same manner as other samples in the quality control laboratory.”

The U.S. agency also noted that the facility needs separate or defined areas, or such control systems for the firm’s operation that is necessary to prevent contamination or mix-up during aseptic processing.

Aseptic processing is a system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

While most observations related to the facilities aseptic processing conditions, other remarks made by the FDA included appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile and the need to educate and train employees involved in the manufacture, processing, and packaging of medicines.

After the FDA released the document, some pharmaceutical companies and stock analysts expressed concerns over a possible delay for Nabota's U.S. sales approval.

In response to such concerns, Daewoong released a statement claiming that the FDA typically issues the document after inspection and it poses no threats to the company’s winning the sales approval.

“Contrast to certain claims raising concerns of a serious defect, the problems mentioned in the observations can be solved,” a company official said. “Also, the FDA report does not indicate violations of GMP, but rather observations, which is different from news reports that suggested the report pointed out violations related to the company's manufacturing processes.”

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