Recently, a company received this observation ….
…. Required records are not maintained at a location that is reasonably accessible to responsible officials of the manufacturer and to employees of the FDA .and were not made readily available for review and copying by the FDA.
Specifically, your firm’s employees do not have access to quality documents and records that apply to the products you are responsible for overseeing and sale of, such as, manufacturing records, complaint and CAPA feedback records, and relevant quality procedures.
To read more about this observation as well as observations pertaining to manufacturing controls, laboratory controls, sterile manufacturing controls and medical devices, see our new issue 1034.