FDA 483 - Delta Pharma, Inc. - June 02, 2023

The FDA conducted an inspection of Delta Pharma, Inc., an outsourcing facility located at 114 W Mulberry St, Ripley, MS 38663-1709, from May 22, 2023, to June 2, 2023. The inspection report, issued to President Stuart P. Simpson, identified one observation regarding deficiencies in aseptic processing areas.

Specifically, the firm failed to perform environmental monitoring (EM) sampling (viable and non-viable) in the ISO 7 room during a media fill conducted on May 26, 2023. This absence of EM sampling during the media fill means the firm lacks assurance of control over the ISO 7 room. Furthermore, this media fill was not representative of the firm's established drug production process, which requires EM samples of the ISO 7 room to be collected no less than one time during filling. This observation indicates a deficiency in the system for monitoring environmental conditions in aseptic processing areas. The inspection was conducted by Sonya M Edmonds, Investigator, and Lareese K Thomas, Field Administrative Personnel.