FDA 483 - MPRX, Inc. - November 22, 2019

During an inspection from November 18-22, 2019, of MPRX, Inc. dba Medical Park Pharmacy, a producer of non-sterile drugs located at 8230 Elmbrook Dr Ste 600B, Dallas, TX 75247-4144, several observations were made.

Observation 1 noted that drug products were released with strength, purity, or quality issues. Specifically, in October 2019, [(b)(4)] of [(b)(4)] lots were produced using expired bulk drug substances/chemicals, including Phenylephrine, Desonide, Dexamethasone, Liothyronine, Acesulfame Potassium, Gabapentin, and Cyclobenzaprine.

Observation 2 detailed issues with equipment calibration. The scale for weighing bulk drug substances/chemicals had not been calibrated since the firm moved locations. Additionally, the weighing of ingredients/components for each lot was not verified, and Formula Worksheets did not list ingredients and quantities in the order of the manufacturing process.

Observation 3 indicated inadequate measures to prevent cross-contamination for highly potent drugs. The firm did not document cleaning of the [(b)(4)] hood and the hood used, nor non-dedicated equipment (e.g., [(b)(4)]), to control cross-contamination.

Observation 4 reported the presence of vermin, with an insect observed on the pharmacy floor where compounding activities