FDA says no to visual exam for particulates; Purdue recalls 388 lots of oxycontin.

Purdue Pharma endured two inspections of its plant in Totowa, NJ, in 2001 and, not surprisingly, got a Nov. 9 warning letter, including a citation for failing to keep stearyl alcohol tainted with black particulates from being used in manufacture of an unnamed product.

The quality unit drew fire for the lapse, as well as for not informing the supplier of the problem. The vendor was described by FDA as unqualified and the agency insisted that "the appearance of black spots in one of your products is not new at your firm." The letter noted that such an incident took place in 1998, to which Purdue responded at the time that documents related to the inquiry were not located, but that SOPs would be tightened to require full documentation of such efforts in the future.

FDA responded to Purdue's assertion that "it is understood and generally accepted by industry that some baseline levels of stainless steel may be present" in drug products as a result of equipment wear and tear with the rebuttal that visual examination and removal of particulate matter was not sufficient to render a contaminated lot of stearyl alcohol acceptable for use. According to the warning letter, Purdue recalled 388 lots of oxycontin tablets as a result.

Oxycontin, a pain reliever, is being diverted for sale as a drug of abuse.

The agency also hit the firm for annual product review documents with "incorrect and/or incomplete information" and stated that corrections proposed in a Sept. 27 response to the 483 would be confirmed in a subsequent inspection.

At press time, calls to company executive Robin Hogan, whose title was not given, had not been returned. Doc. 11200W