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The QMN Weekly Bulletin

Contract Manufacturer Hit with Warning Letter Over Labeling Issues

May 13, 2016

A contract manufacturer is being hit with a warning letter over a slew of GMP and labeling violations.

The warning letter stems from a Jan. 12 to Feb. 13, 2015 inspection of Texas-based Chemolee Lab that turned up six significant violations at the facility, which produces OTC and finished products for other companies.

The first major complaint in the Feb. 23 letter, which was posted online March 8, concerns Chemolee’s failure to investigate unexplained discrepancies in batch production or determine the specifications for any batch components it produces. This includes batches of acne cream that failed microbial tests and other, unspecified products that failed three different microbial tests.

Chemolee concluded that the failures were due to an improperly cleaned transfer pump and set up new procedures, only to have another product fail five microbial tests the next month. FDA officials determined that Chemolee’s “response to the initial contamination event was ineffective,” and the company should have expanded its inspection to other products. The agency notes that it encountered similar issues during a 2011 inspection.

Another complaint concerns Chemolee’s failure to maintain and properly sanitize equipment, with the letter citing concerns with the company’s reverse osmosis water system for topical drugs. The inspectors pointed to a leak in the reverse osmosis system and were informed by the company’s director of operations that the system “had been leaking for more than six months.”

Based on this information, the FDA concluded that the company’s monitoring, inspection and repair of the system was insufficient to maintain a validated state. More generally, the agency noted that it has no assurance that the company’s cleaning and sanitization methods are adequate, stating that there were no cleaning procedures in place for certain equipment associated with the microbial test failures.

The FDA also dinged the firm for a lack of specificity in its procedures for handling ingredients, with the letter asserting that Chemolee’s processes for compounding, filling and hole times all lack defined process parameters, such as mixing times and blending speeds.

“Your firm has no evidence that your manufacturing processes have been validated,” the letter states.

In a similar vein, the warning letter contends that the company’s lab controls lack “scientifically sound and appropriate standards and test procedures” for ensuring product potency and purity.

In addition, the agency cited the company for eight labeling claims for OTC products produced at the plant that are only permitted for prescription drugs.

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