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Regulatory News | 18 June 2014 | By Alexander Gaffney, RAC
Unless you've been paying close attention, you'd be forgiven for missing one of the biggest stories at the US Food and Drug Administration (FDA) this year. While the agency has been sending letter after letter to manufacturers in India, until this week the agency hadn't sent a single Warning Letter to a company in China—a curious trend following the 38 sent to Chinese companies since 2008 and the six it sent to them last year alone.
The lapse in Warning Letters has come just as FDA has reported difficulties in obtaining visas for its inspectors following an increase in funding made available in the Food and Drug Administration Safety and Innovation Act (FDASIA).
Despite assurances made by the White House and Chinese officials, the "substantial increase in the number of US food and drug inspectors stationed in China" never quite materialized to the extent promised. The agency said in May that it has 13 staff stationed in the country. It is seeking to increase that number to 27, it told Congress.
Part of the problem may be the prospect of additional Warning Letters. As FDA has upped its scrutiny of manufacturing facilities in India, so too has the number of major Warning Letters and import bans increased.
Based on data maintained by Regulatory Focus, 11 Indian companies have been found to be violating current good manufacturing practices since May 2013, resulting in FDA banning imports from all 11 companies.
If FDA stations more inspectors in China, the number of Warning Letters may also increase, putting pharmaceutical exports in the country at risk, Focus postulated in December 2013. In addition, many global regulators often follow FDA's lead on inspectional matters, meaning a loss of market access in the US could also close of markets in Europe, Australia, Canada and Japan.
And without that increased enforcement staff, it's been an unusually slow year for FDA Warning Letters to companies based in China.
But now, after a six-month period during which no letters were sent, that streak has ended.
This week FDA released the text of a letter sent 10 June 2014 to Tianjin Zhongan Pharmaceutical Co., a Tianjin, China-based active pharmaceutical ingredient (API) manufacturer.
The company, FDA said, was found to be manufacturing products outside of compliance with current good manufacturing practices (CGMPs).
Cleaning was a major concern at the facility, FDA alleged in its letter. In one instance, FDA inspectors found a manufacturing workshop "with various levels of contamination and foreign objects inside, including what looked like the remains of a pen" in one piece of equipment. The company also failed to maintain cleaning logs, FDA said.
In another case, the company made changes to its methods of API production, substituting one piece of equipment for another, which eliminated one part of the manufacturing process. The company did not evaluate this change to determine if it would have any effect on the drug, FDA observed. Elsewhere, FDA found that production equipment was not properly qualified, including tests to ensure production surfaces were not reactive, additive or absorptive.
FDA inspectors found the company also failed to "adequately control" its Certificates of Analysis (COAs), which are used to pass along information about the attributes of a production batch.
"Your employees in the Foreign Trade Office generated and issued COAs for your products, and your Quality Unit did not control, or retain records of all such COAs," FDA wrote. Alarmingly, FDA said it found evidence that one batch of API was imported into the US, but using a different COA than one maintained by the company in its records for that batch.
FDA called this a "significant recordkeeping deficiency."
The company is not yet subject to an import alert, though FDA's letter threatens that unless the company makes improvements, it soon could be.
FDA Warning Letter to Tianjin Zhongan Pharmaceutical
Tags: Warning Letter, Inspection, CGMP