Warnings to Two Compounders Make 2015 Total 18

The FDA’s crackdown on compounding pharmacies that lack sterile processing controls continued with warning letters to facilities in Florida and Arkansas — bringing to 18 the number of compounders cited this year.

In a July 16 letter, the FDA faulted Boca Raton, Fla.-based KRS Global Biotechnology for failing to monitor the air and condition of its clean room on a daily basis. Investigators from the agency’s Florida district office observed operators manually stoppering vials with their gloved hands. They also cited KRS for not having defined areas or other controls to prevent contamination or mix-ups.

During the March 4 to March 17, 2014, inspection, labels on some drugs were missing the date of compounding, storage and handling instructions and a statement saying they are compounded drugs. Some products also failed to list active ingredients or information on adverse event reporting.

In a June 25 letter, the FDA rapped Little Rock, Ark.-based SCA Pharmaceuticals for failing to investigate sterility failures, batches containing particulates and daily pressure differentials that were out-of-specification. Investigators from the Dallas district office also dinged the firm for not monitoring its clean room areas and testing sterile drugs for endotoxins.

Like KRS, SCA failed to ensure that all product labels included information on adverse event report and other required information statements.

The FDA urged the compounders to conduct a comprehensive review of their operations and to hire outside consultants with sterile drug manufacturing expertise to bring their shops into compliance.

Most recently, the agency issued a Form 483 to Montana compounder for inadequate sterile controls.

SCA’s President and CEO Gene Graves said his firm hadn’t heard from the FDA following its April 2014 response to a Form 483, and has not had an inspection since then. The company believes it satisfied the FDA’s observations and made other significant quality improvements in the subsequent 15 months, but will cooperate fully to ensure compliance, he added.

KRS did not return a request for comment by press time. Read the warning letters at www.fdanews.com/07-23-15-KRSGlobal.pdf  and www.fdanews.com/07-23-15-SCA.pdf. — Kellen Owings