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Q1 FDA cGMP warning letters

By Nick Taylor , 23-Mar-2011

in-PharmaTechnologist presents a round up of current good manufacturing practice (cGMP) related warning letters sent by the FDA in the first quarter.

The US Food and Drug Administration (FDA) sent Toxin Technology a warning letter last month following an August 2010 inspection. Toxin sent two responses, in September and October, to the FDA 483 that followed inspection of its active pharmaceutical ingredient (API) testing laboratory.

However, responses arrived more than 15 business days after the 483 was issued, says the FDA, and so were ignored by the agency. The FDA will consider the 483 responses, along with any other material from Toxin, as a follow up to the warning letter.

Issues raised in the warning letter include failure to: assure materials are properly tested; accurately report results; appropriately validate an analytical method; and have staff qualified by education, training and experience.

Hawkeye Jensen received a warning letter this quarter following inspections of its Pennsylvania, US facility in July and August 2010. The FDA writes Hawkeye failed to follow written cleaning and maintenance procedures and responsibilities relevant to the quality control unit.

Failure to identify attributes, such as solubility, and process parameters, such as temperature, to ensure consistent production of a wound cream is also noted by the FDA. In a September 2000 inspection the FDA made a similar observation.

In January Baxter received an FDA warning letter about its plant in Jayuya, Puerto Rico. The FDA inspected the site in July and August 2010. In the warning letter the FDA details failure to ensure the container closure system provided adequate protection.

Sanofi-aventis received an FDA warning letter after the agency identified shortcomings in contamination-prevention procedures at its Frankfurt am Main, Germany plant in September 2010.

Responses were sent by Sanofi in October 2010 and January 2011 but the FDA still had concerns and on February 9 sent a warning letter to the German facility .

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