FDA 483 - VGXI, Inc.

VGXI, Inc., a DNA Plasmids Contract Manufacturer in The Woodlands, Texas, received an FDA Form 483 citing multiple deficiencies. The inspection revealed inadequate change control for manufacturing equipment, insufficient instructions in batch records, and an operator's failure to follow established SOPs. Additional concerns included unvalidated shipping processes, deficient material management, inadequate visual inspection operator qualification, a deficient pest control program, and inadequate procedures for system maintenance.