MedPark Pharmacy, LLC FDA Warning (2018)

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in MedPark Pharmacy, LLC's operations or product claims.

Potential Health Risks

Division of Pharmaceutical Quality Operations I10 Waterview Blvd, 3rd FLParsippany, NJ 07054Telephone: (973) 331-4900FAX: (973) 331-4969

In your response to Form FDA 483 Observation 3, you state that “MedPark uses(b)(4)to clean the sterile isolator and that their cleaning procedure is one that is recommended by the manufacturer and has been shown to meet the requirements for USP General Chapter 797>.” You also state that “MedPark Pharmacy will purchase sterile wipes packed individually to maintain each wipe’s sterility and use them prior to performing sterile production. In addition, MedPark Pharmacy will use(b)(4)on a going forward basis.”However, you firm did not establish a dateline for when the purchased of the sterile wipes will be completed and/or any interim corrective actions to be taken.

In response to Form FDA 483 Observation 2, you stated that “MedPark Pharmacy standards require that the isolator is fully and thoroughly cleaned and purged prior to any compounding being performed in the isolator and, to date, all tests indicate that the isolator meets USP General Chapter 797> requirements for sterility.”  We recommend you thoroughly assess your cleaning and disinfecting procedure to ensure that the ISO 5 areas are being adequately and consistently disinfected to achieve aseptic conditions for the processing of drug products intended to be sterile.

Regulatory Context

In regards to the Form FDA 483 Observation 1(ii), your firm did not address the concerns of our investigators regarding the handling of pre-packaged, capped and stoppered sterile vial packs opened in an unclassified room with and without gloves. No corrective action was indicated to be implemented to avoid this occurrence.