Wyeth warned by FDA over manufacturing standards in Puerto Rico

The FDA has warned Wyeth over its manufacturing standards at its Puerto Rico facility.

The American drug regulator found that the factory did not comply to the Current Good Manufacturing Practice regulations for the manufacturing, processing, packaging or holding of Triphasil-21 tablets, Prempo, Advil caplets, Effexor tablets, Duofeln tablets, Gestodene tablets, Caltrate 600mg tablets and Inderal LA 60mg tablets.

In June last year, the presence of an unknown “peak” was discovered in batches of Triphasil 21 and 28 oral contraceptive pills during analysis, meaning that they were contaminated with an unknown agent. Eventually it was traced to a chemical found in the drug’s Nylon packing.

However, the FDA said it had concerns with Wyeth’s investigations.

In a letter to the company’s chief executive, the acting district director for San Juan, Maridalia Torress, said: “[An] effort to identify the unknown peak and to conclude the stability investigation was not made until the issue was raised during the current inspection. This example raises serious concerns regarding the timeliness of your investigations.

“Your response also stated that each complaint is taken seriously and that Wyeth is committed to improvement. Yet, the response failed to provide any details on the specific corrective actions that were taken to address future occurrences of these complaints.”

Ms Torress said that the FDA had recorded 17 other examples where unknown peaks were recorded, but where the subsequent investigations were inadequate.

She said: “[Each] of these investigations has failed to determine the root cause or source of the contamination, or propose any corrective or preventive measures to address future occurrence of the contamination.”

According to the Associated Press, Doug Petkus, a Wyeth spokesman, said that none of the issues affected the safety or effectiveness of the drugs and that the company was trying to resolve the problems.

Prudential analyst Tim Anderson is quoted by the news agency as saying that his “best guess is that this will have only a marginally negative impact on Wyeth”.

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