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

Source: https://www.keypedia.com/records/483/mprx-inc/3fef0d42-1066-4047-a431-fa172a4e5bf6

> FDA 483 for MPRX, Inc. on November 22, 2019. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: MPRX, Inc.
- Inspection Date: 2019-11-22
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: 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

## Related Officers

- [CO CDER OMQ](https://www.keypedia.com/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

Company: https://www.keypedia.com/companies/mprx-inc/6a21dda4-731f-41a0-aa36-62532aec933c

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9