FDA 483 - Garda Rx LLC - June 06, 2017

On June 6, 2017, the FDA issued a Form 483 to Garda Rx LLC, located at 1596 Hancock Ave, Apollo, PA 15613-8404, following an inspection conducted from June 1-6, 2017. The inspection was of a producer of non-sterile drugs, and the report was issued to Martin J. Garda, President and Owner.

The inspection revealed insanitary conditions during the production of non-sterile drug products. Specifically, the (b)(4) countertop used for production had exposed particle board on a side adjacent to the work surface. Additionally, visible residues and filth were observed adjacent to the non-sterile production area on a shelf holding non-sterile production equipment, on the balance used for non-sterile drug product production, and in the (b)(4) used for non-sterile drug product production. These observations indicate deficiencies in maintaining a clean and sanitary environment for drug manufacturing.