Drugs

Contract Testing Lab Gets Warning Letter

FDA has issued Camden, NJ-based contract testing laboratory Sure-Biochem Laboratories a just-posted Warning Letter after a 10/2022 inspection cited significant GMP violations associated with the firm’s microbial testing of finished drug products.

For example, the agency letter says the testing lab “failed to follow required laboratory control mechanisms and to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.” It failed to establish and follow procedures for growth promotion testing involving its microbiological media to assure suitability before use.

FDA said Sure-Biochem’s Form FDA-483 response to the inspection finding was inadequate because it did not address how it will review the validity of previous results using alternative methods, or how the company will inform clients about potentially noncompliant analyses. “You also state that you will perform method suitability verifications for each type of product, but do not detail the actions you would take if suitability verifications are found inadequate,” the letter said.

Additionally, the letter said the company failed to establish an adequate quality unit (QU) and associated procedures. For example, the QU failed to adequately retain documentation for the review, approval, or rejection, of laboratory testing materials such as buffers, reagents, and media. It also failed to “ensure procedures were followed to document and retain records such as laboratory investigations, corrective action and preventive action plans (CAPA), and change controls,” according to the letter.

The Warning Letter also recommended that Sure-Biochem retain a third-party consultant to assist with meeting GMP requirements.

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