Information that would indicate a manufacturing location is not in cGMP compliance may include a recent violative inspection or pending compliance action. Manufacturing location Address where manufacturing takes place. A manufacturing location may be the applicant s establishment or a contract facility. Days Calendar days 4. Background Section 351 of the Public Health Service Act provides the regulatory authority for licensing biological products and the establishments where these products are manufactured.
Similar requirements exist for drugs and medical devices.
Many firms that manufacture biological products also manufacture drugs or devices handled by other Centers, so enforcement actions may be initiated by the Centers responsible for those products or the field organization. It is important that we are aware of all compliance actions for a manufacturing location before approving applications or supplements that represent important manufacturing changes. The applications divisions may submit compliance status check requests for submissions other than those listed, at their discretion. In general, CBER will approve a submission only when the compliance statuses of the manufacturing locations affected by the submission are acceptable. An exception may be granted when the submission is intended to help the applicant achieve compliance or improve the safety of the product.