An FDA warning letter told a Hong Kong-based API seller that inspectors found serious quality issues at its distribution facility there and at one in Tempe, AZ. One reason for the lapses, the agency said, appears to be that the ingredient maker has no quality-control unit to make sure it meets GMP standards.
"During the inspection, you stated you did not have a quality unit, provided no written documents describing the roles and responsibilities of a quality unit, and had no written procedures for quality activities," the letter said.
The letter to cbsChem sent Jan. 31 and posted this week by the FDA laid out problems found during inspections in April and June 2013. According to FDA files, a sildenafil citrate product from the company was put on import alert in 2012 and several doxycycline products were added in August of last year.
Essentially, the company has no record keeping for its active pharmaceutical ingredients, so there is no way of knowing where they were made, by whom or whether they meet specifications, inspectors said. In Hong Kong, inspectors found 23 lots with no batch numbers, manufacturing dates, expiration or retest dates. It also said ingredients could easily get mixed up because cbsChem stored returned products in unmarked bags on the same shelves as products it was bringing into the distribution site. Some of the same problems were found at its facility in Arizona. Again, inspectors said there were no records to indicate where the ingredients were made or by whom. The agency suggested the Hong Kong company get help from outside experts and warned if it didn't, the FDA may not allow it to distribute in the U.S.
China is one of the primary sources of APIs for drugmakers globally because of its cheap prices, but the country has been unable to keep up with the rapidly growing business. The FDA is in the process of adding inspectors who will be stationed there, after China delayed for a year providing them with visas so the FDA could move them there.