FDA 483 - La Vita Compounding Pharmacy, LLC - March 11, 2020

During an FDA inspection, the firm was cited for using non-pharmaceutical grade Methylcobalamin active ingredient, purchased from (b)(4), in the production of Methylcobalamin solution for injection. (b)(4) lots of this ungraded active ingredient were used in (b)(4) finished product batches, including (b)(4).

Personnel gowning procedures were found to be inadequate. On March 9, 2020, Sterile Technician (b)(6) allowed the sleeves of a non-sterile cleanroom suit to contact the ISO 8 ante room floor before entering the ISO 5 zone to produce Methylcobalamin batch 183570@8 BUD 9/5/20, with uncovered and non-sanitized sleeves observed within the ISO 5 space.

The ISO 5 classified aseptic processing areas exhibited particle-generating and visibly dirty equipment. Observations in the ISO 7 buffer room included rust-like discoloration on a chair and garbage can, and extensive cracks on the (b)(4) between the ISO 7 buffer room and ISO 8 ante room, with materials entering the ISO 7 room passing over these composite boards.

Furthermore, the firm failed to adequately evaluate and take remedial action for microbial contamination. An airborne viable environmental monitoring OOS (15 CFU) was identified on January 25, 2019, at location (b)(4) in the ISO 7 buffer