What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee

Published: Oct 11, 2016

What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee October 10, 2016
By Alex Keown, BioSpace.com Breaking News Staff

HYOGO, Japan – Employees at Nippon Fine Chemical, a maker of ingredients for pharmaceutical drugs, really did not want inspectors from the U.S. Food and Drug Administration (FDA) to conduct a quality control investigation—so much so that the employees formed a human barricade to keep the inspectors out of areas in the facility.

In a warning letter issued by federal regulators to the Japanese company, first reported by Stat News, inspectors attempted to visit the factory in December, but were barred access to many areas of the facility.

“During the inspection, your firm limited the investigator’s access to the quality control laboratory. The quality control manager directed employees to stand shoulder-to-shoulder, barring our investigator from accessing portions of the laboratory and the equipment used to analyze drugs for U.S. distribution,” the FDA said in the letter.

Additionally, the FDA said employees refused to provide the inspectors with copies of documents that would allow them to review complaints against the manufacturing company. Complaints that include allegations the drugs contained glass, hair, cardboard, metal, product discoloration and last, but certainly not least, a black spider. The FDA said the company “limited the inspection” by refusing to provide copies of the records.

The FDA also said the quality assurance manager at Nippon Fine Chemical blocked attempts by inspectors to take photographs of equipment used to manufacture drugs for sale in the United States.

As a result of the impediments, the FDA said Nippon Fine Chemical had been placed on Import Alert as of Aug. 8. That placement effectively blocks the Japanese-made products from entering the country. The FDA said until it is allowed to investigate the facility and ensures it is compliant with regulatory standards, the company stands to cause drug companies using its facility to have their products blocked for approval or sales. Additionally, the FDA said products made at Nippon Fine Chemical and shipped to the United States are subject to refusal of admission.

Nippon Fine Chemical has been given 15 days to respond to the letter, which was dated Sept. 26. Stat News said it attempted to contact Nippon Fine Chemical for a response, but had not heard back from company representatives.

According to Nippon’s website, the company makes highly purified phospholipids, camphor, which is a cough suppressant, acid chlorides and other chemicals. Also on its website, the company notes its highly-experienced quality assurance staff, which includes members who have “experienced FDA and EU audits.”

“NFC enthusiastically accepts audits by outside corporations and entities to allow them to be sure of NFC's quality assurance system,” the company said on its website.

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