FDA 483 - Jeffreys Drug Store - August 04, 2017

The FDA Form 483 documents deficiencies at a facility involved in aseptic processing of drug products. The primary issues relate to inadequate control of classified areas and procedures for preventing microbiological contamination.

Specifically, certification activities for ISO 5 classified areas were found to be deficient. These areas were not certified under dynamic conditions, and smoke studies were either inadequate or not performed. Examples include: * Laminar hood (b)(4) (serial # (b)(4)) certified on 7/21/16: No dynamic conditions certification, no smoke study. * Laminar hood (b)(4) (serial # (b)(4)) certified on 9/12/16: Incomplete smoke study documentation, lacking details on performance and conditions. * (b)(4) (b)(4) (b)(4) (serial # (b)(4)) certified on 11/30/16: No dynamic conditions certification, no smoke study, and no viable air or surface sampling performed. * Laminar hood (b)(4) (serial # (b)(4)) certified on 5/9/17: No dynamic conditions certification, no smoke study, and the (b)(4) was not evaluated under dynamic conditions.

Furthermore, procedures to prevent microbiological contamination of sterile drug products are not established, as the firm does not perform media fills and lacks procedures for conducting them.

Ase