Findings citing 21 CFR 211.160

Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, 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, as required by 21 CFR 211.160(b). For example, samples of your umbilical cord derived products are frozen and thawed prior to sterility testing. Freezing samples has the potential to destroy or compromise any microbial content in the samples before testing, if present; therefore, any contamination that was present prior to freezing may not be reliably detected.

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit (QU) failed to perform adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure the following: Establishment of adequate written responsibilities and procedures applicable to the…

Your firm failed 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 (21 CFR 211.160(b)). You failed to ensure components and drug products are adequately monitored for microbiological…

Your firm failed 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 (21 CFR 211.160(b)). You failed to adequately validate your alternative (b)(4) microbiological test methods. Your firm…

Your firm failed to document at the time of performance required laboratory control mechanisms and to record and justify any deviations from required laboratory control mechanisms (21 CFR 211.160(a)). Your control over microbiological laboratory records was inadequate. Our investigators found that microbial plates (for sterility, environmental monitoring, and water samples) in incubators lacked appropriate documentation. For example, you did not have raw data and information…

Your firm failed 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 (21 CFR 211.160(b)). You failed to adequately validate your alternative microbial methods used to test drug products to…