UPDATED: FDA finds DPT's Center of Excellence not so sterile

Warning letter notes sterility test failures in 6 lots in 2 years

September 6, 2012 | By Eric Palmer

The FDA has raised serious concerns about the sterility procedures at DPT Laboratories' Center of Excellence for Sterile and Specialty Products in Lakewood, NJ, particularly over an ointment intended to help heal skin wounds and burns.

The contract manufacturer, in a statement, says it is working with the FDA to fix its problems. DPT, which in July was acquired by a private equity firm, invested $40 million in an expansion of the plant in 2010 so that it could specialize in aseptic production of sterile dosage meds. But FDA inspectors, during visits in February and March, found problems with microbial contamination and zeroed in on the company's inability to get to the root of the problem, according to a warning letter posted this week on the agency's website. It said that after sterility test failures in 2010 and 2011, the company's response has been to retrain employees in aseptic filling procedures, but that clearly hasn't solved the problem.

The warning letter says that after "the May 2011 sterility failures and then the failed media fill conducted in June 2011, you committed to completing three successful media fills prior to resumption of manufacturing," but the latest lapse indicates that retraining is not the answer.

The letter says DPT has seen 6 lots of Santyl Ointment fail release testing since the plant was approved in November 2010. "These sterility failures indicate that your firm does not have adequate aseptic procedures in place." In June 2011, the letter says, a "Bacillus species was identified in the samples incubated for the media fill," and again inspectors were unimpressed with how the company handled the investigation.

Read rest of article at UPDATED: FDA finds DPT's Center of Excellence not so sterile - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-finds-dpts-center-excellence-not-so-sterile/2012-09-06#ixzz25iH6ncrJ 
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FDA Warning Letter to DPT Lakewood, LLC

On August 27, 2012, the FDA issued a warning letter to DPT Lakewood, LLC, located in New Jersey.  The beginning of the letter states:

During our February 15 to March 7, 2012 inspection of your pharmaceutical manufacturing facility located at 1200 Paco Way, Lakewood , NJ, an investigator from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product, Santyl Ointment, to be adulterated within the meaning of section 501 (a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351 (a)(2)(8)], in that the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

We have reviewed your firm 's response of March 22, 2012, and note that it lacks sufficient corrective actions.

To read the remainder of this warning letter, click here.