- The FDA issued a warning letter to the Chinese pharmaceutical supplier Zhejiang Hisun Pharmaceutical in December of last year, revealing the company was the subject of 61 complaints related to subpotency and out-of-specification impurity levels between 2012 and 2014.
- In March of 2015, FDA inspectors investigated four of those complaints and found numerous deficiencies in Hisun's controls for preventing the manipulation of sample data. Additionally, culture plates used to test microbial levels in active pharmaceutical ingredient (API) batches were cracked and deformed.
- As a result of the inspections, Hisun was placed on import alert in September of 2015, which blocked the import of at least 15 products into the United States. The warning letter cautioned Hisun that failure to correct these flaws in their manufacturing practices would result in the continued blocking of goods made in their facilities.
Recently, there have been broad concerns over the quality of manufacturing practices among pharmaceutical suppliers in China and India. Numerous firms in both countries have been the subjects of FDA warning letters, including large Indian firms like Sun and Dr. Reddy's.
India and China are the top two manufacturers of the base ingredients found in pharmaceutical drugs, according to Bloomberg. However, there are very few FDA inspectors dedicated to investigating the hundreds of facilities in the countries.
This has led to legislative concerns in the United States. The House Committee on Energy and Commerce recently sent a letter to the Government Accountability Office, asking it to assess the FDA's ability to inspect foreign manufacturing facilities.
While investigating the complaints against Hisun, FDA inspectors ran into problems accessing records. In one incident, a Hisun analyst was asked to provide a USB drive removed from a computer used in testing. Instead, the analyst pocketed the drive and walked out of the room. Fifteen minutes later, management provided what was said to be the USB drive in question, but the FDA inspector had no means of determining whether it was the original.
An inspection of a high performance liquid chromatography system found the audit trail for testing API batches had been disabled in February, 2014. When questioned why the audit trail had been deactivated, a Hisun analyst told the FDA a former employee had disabled it and it had not been reactivated. In a second system, raw data for 17 of 61 injections had been deleted.
FDA inspectors found other evidence of improper data manipulation related to testing done in May 2014. Trial testing had been performed but all of the sample set data was deleted and nothing had been recorded in the instrument use logbook.