New York Compounders Warned for Lax Sterile Drug Production

The FDA slapped warning letters on two more drug outsourcing facilities for sloppy sterile processing, bringing to seven the number of compounders cited for sterile manufacturing deviations in the past six months.

In nearly identical letters dated March 27, the agency says Alexander Infusion of New Hyde Park, N.Y., and Brooklyn-based Kings Pharmacy allowed employees to process sterile drugs without protective clothing and didn’t make sure that cleanroom equipment such as protective hoods adequately prevents products from being contaminated.

During Alexander’s June 23 to July 9, 2014, inspection, investigators from the FDA’s Jamaica, N.Y., office observed workers with exposed hair and sterile gloves being worn over nonsterile gloves processing sterile drugs, the warning letter says. The compounder also lacked procedures for cleaning and disinfecting its cleanroom and equipment.

Investigators from the New York City office witnessed Kings Pharmacy employees also wearing nonsterile garments in one of the cleanroom areas, the warning letter says.

Neither firm had written procedures to prevent contamination or systems to monitor the quality of the cleanroom environment, the FDA says.

The agency also dinged both firms for failing to state that their drugs were compounded on product labeling and for failing to submit reports identifying the drugs they compounded in the six months prior to registering as an outsourcing facility, as required by the Drug Quality & Security Act.

The FDA told the compounders to conduct a comprehensive review of their operations, with an eye on sterile processing. The agency also urged them to hire outside consultants with sterile drug manufacturing expertise to bring their shops into FDA compliance.

Kings Pharmacy owner and President Ron Del Gaudio said that the company is working with the FDA to correct all of the issues raised in the warning letter. Alexander Infusion declined to comment.

Poor microbial contamination control is now a top Form 483 and warning letter observation. The focus to date has been on compounding pharmacies, but no FDA- or EU-regulated manufacturer is exempt from those countries’ purity laws. Review your manufacturing process with Manufacturing Sterile Products to Meet EU and FDA Guidelines.