Do your employees have access to the records they need?

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.

Leave a Reply

Your email address will not be published. Required fields are marked *

Search GMP Trends

Did you know: Our entire report archive has been indexed! This means, our members can search across thousands of 483 observations and pinpoint the exact info they need!