A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. have landed in the FDA’s crosshairs thanks to quality shortfalls, poor testing standards and more.
The FDA earlier this month issued separate warning letters to drug ingredient firms Nuowei Chemistry and Innovation Pharmaceutical. Given the scope of the production infractions, both companies have been slapped with import alerts, according to the warning letters, which were posted to the FDA’s website on Tuesday.
Nuowei received its write-up after an FDA inspection of its facility in Xuancheng, China, last September. Innovation Pharmaceutical’s reprimand followed a record request for its Chengdu plant by the U.S. regulator last April.
Nuowei—which previously responded to a Form 483 from the FDA in late September—was written up by the FDA on three points concerning API purity, adherence to manufacturing standards and proper equipment maintenance.
On the first point, the FDA said that the company’s testing methods for impurity analyses were based on the Chinese Pharmacopoeia rather than the United States Pharmacopeia used to set quality standards for medicines in the U.S.
More broadly, Nuowei’s quality unit lacked the oversight needed for drug ingredient production, the FDA continued in the warning letter. FDA inspectors specifically noted that the company’s quality unit lacked stability data to support retest or expiration dates of APIs.
Aside from the key points outlined in the warning letter, the FDA claimed that Nuowei “does not operate an effective quality system” and called on the company’s management to “immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.”
As it stands, Nuowei has communicated to the FDA that it will no longer produce drugs for the U.S. market and that it has de-registered its facility as a drug manufacturer with the agency.
Innovation, while still in hot water with the FDA, appears to be in a much better place than its API compatriot.
The FDA outlined just two complaints in its write-up of Innovation, homing in on the company’s testing procedures and quality standards.
According to the drug regulator, Innovation hasn’t shown that it’s adequately testing each shipment of incoming materials used in pharmaceutical manufacturing. Further, the company’s quality unit has failed to adequately monitor its operations, with the FDA again focusing on the firm’s oversight when it comes to approving or rejecting incoming materials.
To help Innovation right the ship at its facility, the FDA has recommended that the company enlist a manufacturing consultant.