FDA slaps 2 US manufacturers with warning letters for lax testing and operations

The FDA recently hit two small U.S. manufacturing companies with separate warning letters that cited lax testing and operational procedures at each of their production locations.

The regulatory agency slapped RemedyRepack with a warning letter dated May 11 that outlined “significant violations” of cGMP regulations following an inspection of its Indiana, Pennsylvania, facility conducted Nov. 7-10.

The company was cited with four observations: failing to keep track of cleaning and equipment maintenance, documenting discrepancies of batch failures and products meeting specifications, quality control issues and the potential for cross-contamination of drug products.

In the letter posted to the FDA website, the agency said RemedyRepack packaged and distributed various drug products that lacked product-specific packaging validation protocols with preapproved acceptance criteria.

“You also experienced numerous deviations for tablets that broke during packaging, and your firm was aware that small tablets do not run well on your packaging machine,” the agency said. “You also failed to adequately qualify your drug packaging equipment. Though you provided a procedure titled, 'Validation Protocol,' you lacked adequate equipment-specific protocols to reveal the limits of capability of the equipment you use to package drug products.”

The company was also dinged for not having separate or defined areas to prevent contamination or mix-ups. RemedyRepack repackages non-penicillin beta-lactam drugs at the same location as non-beta-lactam drugs. “Complete and comprehensive separation of beta-lactam repackaging operations is essential due to the severe patient risk posed by cross-contamination,” the agency said.

RemedyRepack, along with Lupin Pharma, recalled several lots of lisinopril last September after a fragment of metal was found embedded in a tablet.

In a separate warning letter, skin care product maker Mr. Lulu was slammed for an “inadequate” response to a Form 483 filed with the agency in December.

In its letter to the company dated June 1, the agency cited three observations that came from a Nov. 30-Dec. 9 inspection of its manufacturing facility in Claremont, California.

Those observations included failing to conduct tests on final products before they were released for distribution, failing to test incoming drug product components and lacking adequate written procedures for production and process control.