What can an FDA inspector cite a community pharmacy for?

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The correct reasoning lies in understanding the FDA's regulatory scope and specific compliance requirements for pharmacies. While all the options present potential issues, the FDA inspector is specifically empowered to enforce regulations regarding the distribution and handling of drug samples.

Community pharmacies are prohibited from selling or dispensing drug samples. Drug samples must be provided free of charge under specific conditions, primarily to healthcare practitioners for office use or evaluation as per FDA regulations. If a pharmacy is found dispensing or selling drug samples that should only be provided under specific guidelines, it would be subject to citation.

The other issues, while serious, may fall more under the jurisdiction of state pharmacy boards or other regulatory agencies rather than the FDA specifically. For instance, expired medications and unlabeled medications can be flagged during state inspections for public safety and pharmacy practice standards, while insufficient staff training, although critical, typically would be handled by state boards of pharmacy rather than the federal level. The focus on dispensing drug samples directly relates to the FDA's mandate on drug distribution and ensuring compliance with federal regulations.

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