Biologic Products
Basically, an inspection looks at how a company has established it will manufacture a drug product and determines if this process conforms with good manufacturing practices (GMPs).
Legislative authority and scope of GMPs are defined in section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act. FDA added a "c" before GMP to indicate current Good Manufacturing Practices (cGMP) in order to clarify the progressive and continuous advances and improvements, and subsequent expectations and requirements, that occur in drug manufacturing over time. The regulations for cGMPs are articulated in Title 21 of the CFR parts 210 and 211. These regulations have the force and effect of law and outline what FDA expects from companies. FDA does not have a separate regulation for large pharmaceutical companies as opposed to smaller operations. The regulations have to be flexible enough to adapt to each situation so that all companies are held to the same standards. 
OC has an old mantra, "If you didn't document it, then it didn't happen." Records are a cornerstone for evaluation of compliance with cGMPs and often the primary focus of an inspection.