FDA 483 - La Vita Compounding Pharmacy, LLC - June 08, 2018

During an inspection, the FDA observed multiple deficiencies at a drug manufacturing facility. The firm produced non-sterile and sterile drugs while construction was ongoing in an adjacent area, raising concerns about contamination due to inadequate controls, cleaning frequency, and observed dust in the ISO7 lab.

Specific issues included: * **Contamination Pathways:** Direct entry to the non-sterile lab from a carpeted hallway, and to ISO controlled areas from the non-sterile lab, with an unsealed door leading to the construction area. Pet dogs were present in offices at the end of the carpeted hallway leading to labs, with no indication of carpet cleaning or protective devices. * **Cleanroom Integrity:** Unsealed, loose, and gapped ceiling tiles were observed in the cleanroom, ISO-8 ante-room, and ISO-7 clean-room, not impermeable to prevent contamination. A light fixture above the ISO-5 hood had broken corners. * **Cleaning and Maintenance:** Dust-collecting overhangs in segregated production areas lacked adequate cleaning. Visible dust and dirt were on the ISO5 hood, equipment frames, and doors in the ISO7 room. * **Personnel Practices:** Personnel did not disinfect and change gloves frequently enough. Non-sterile gloves and wipes were used for cleaning in ISO-8 and ISO-7 rooms. A sterile compounding technician used non-sterile wipes and water from an old container for cleaning, left dirty wipes in the ISO-5 hood,