FDA 483 Observations in 503B Outsourcing Facilities

In this issue, we will continue our review of FDA 483 observations in 503B outsourcing facilities; specifically, we will look at the category involving "Unapproved and Unvalidated Components."

UNAPPROVED AND UNVALIDATED COMPONENTS

• Component supplier reports of analysis are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
• The firm's process for evaluating incoming APIs used to manufacture sterile drug products is inadequate in that the firm has not established specifications for or routinely tests for bioburden and endotoxins as part of their release specification.
• You do not have bioburden data for all products to support the end hold times used.
• Bulk drug substances used by your outsourcing facility to compound drug products are not each manufactured by an establishment that is registered under section 510 as required.
• Your firm's quality-control unit lacks the responsibility and authority to approve and reject all components, drug product containers, closures, and drug products.
• Your supplier of an API was changed twice during the year and method suitability was not conducted by the contract laboratory performing the sterility testing on the finished product.

More next week.