FDA issues warning letter Hisun’s API plant in China

FDA issues warning letter to Hisun’s API plant in China

11:07 AM, 18th January 2016
FDA issues warning letter to Hisun’s API plant in China
The headquarters of the US Food and Drug Administration is shown in Silver Spring near Washington. © CNN (File photo)

SILVER SPRING, US: The US Food and Drug Administration (FDA) said that it has warned China-based Zhejiang Hisun Pharmaceutical, which established a joint venture with Pfizer in 2012, for data integrity violations more than three months after banning the company’s products from entering the US.

During March 2015, investigators from the FDA inspected the drug manufacturing facility and identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (API).

These deviations caused the drugs to be adulterated in the methods used for their manufacture, processing, packing or holding do not conform to, or are not operated or administered in conformity with, CGMP, said FDA.

The investigators observed specific deviations during the inspection, including the following:

1.    Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data.

2.    Failure to conduct appropriate microbiological testing on API batches where microbial quality is specified.

“Our investigators found that the firm routinely re-tested samples without justification and deleted analytical data. We observed systemic data manipulation across the facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs. They are responsible for determining the causes of these deviations, for preventing recurrence, and for preventing other deviations from CGMP,” FDA said.

The warning letter was issued because the audit trail was disabled. All supporting raw data was discarded, including sample solution dilutions and balance weight printouts. Sample analyses were not recorded in the instrument use logbook. Test results were deleted from the hard drive and all supporting chromatograms were discarded.

The investigator later discovered the missing data in a backup folder.

The FDA has asked the Chinese API manufacturer to submit a timeline for completing retroactive microbial testing of all potentially-compromised batches via an independent laboratory and also plans for corrective and preventive action management procedure in the future. 

© Worldofchemicals News

0 Comments

Login

Your Comments (Up to 2000 characters)
Please respect our community and the integrity of its participants. WOC reserves the right to moderate and approve your comment.

Related News


BPCL to use Air Liquide’s technology for Kochi petrochem project

KOCHI, INDIA: Bharat Petroleum Corporation Limited (BPCL) said that it has selected Air Liquide Global E&C Solutions, the engineering and construc ...

Read more
Rosneft, BP to dissolve German joint venture

MOSCOW, RUSSIA: Rosneft said that it has signed a binding agreement with BP Plc, to dissolve the existing refining JV Ruhr Oel GmbH (ROG) as they move ...

Read more
Brazil fire: Explosion unleashes toxic gas in Santos

London, UK: A chemical explosion at a cargo warehouse in Brazil has spread toxic gas over the country’s biggest port. The company owners said t ...

Read more
AkzoNobel, Evonik break ground for production JV in Germany

IBBENBUREN, GERMANY: AkzoNobel NV and Evonik Industries said that they have broken ground at the site of their production joint venture for chlorine a ...

Read more
Linde appoints Victoria as member of supervisory board

MUNICH, GERMANY: Linde AG said that it has appointed Dr Victoria Ossadnik (47) to the supervisory board, succeeding Klaus-Peter Muller (71). A doctor ...

Read more
Pemex extends Linde’s nitrogen supply contract in Gulf of Mexico

MURRAY HILL &NEW PROVIDENCE, US: The Linde Group said that it has signed a contract with Pemex Exploracion y Produccion (PEP), a subsidiary of Pet ...

Read more
www.worldofchemicals.com uses cookies to ensure that we give you the best experience on our website. By using this site, you agree to our Privacy Policy and our Terms of Use. X