FDA 483 - Maitland Labs of Central Florida - June 17, 2019

The FDA Form 483 details multiple deficiencies at an outsourcing facility producing drug products, including Epinephrine 1mg/mL, 3mL vials.

Key violations include: 1. **Aseptic Processing Area Deficiencies:** The firm's SOP: ENV-4.018, Rev. 1, "Cleaning and Disinfection of the Facility," is deficient, and cleaning records for the Cleanroom (where aseptic filling occurs) and Formulation Lab (for terminally sterilized products) were unavailable for multiple months in 2018 and 2019. 2. **Environmental Monitoring (EM) Deficiencies:** The firm failed to follow SOP: ENV: 4.001, Rev. 2, "Environmental Monitoring Controls," for the Formulation Lab, conducting EM only twice since March 2018, despite a required frequency of (b)(4). No EM was conducted during filling operations for specific Epinephrine lots. 3. **Aseptic and Sterilization Process Validation Deficiencies:** Media fills were conducted outside the cleanroom, did not simulate actual production, lacked growth promotion testing on the media, and did not include environmental monitoring. Documentation was also deficient regarding vial incubation and 100% visual inspection. 4. **Drug Product Testing Deficiencies:** Sterility and potency testing were not conducted by the Contract Testing Laboratory (CTL) for specific Epinephrine lots. The firm also failed