Is Med-Pharmex, Inc. Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

1. Your firm does not follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. 211.113(b)].  For example, on January 17, 2017, during the aseptic filling of(b)(4), our investigators observed the following aseptic technique deviations:

These instances of poor aseptic technique are critical and similar issues were observed during the previous FDA inspection of your firm, conducted February 8-17, 2016.  In your response, you indicate that retraining of personnel occurred, however you did not evaluate individual aseptic processing operator trends for each operator.  An evaluation was not conducted to determine if aseptic processing operators would require re-certification.  Your response states these observations are not standard practice, but you did not provide a written Standard Operating Procedure to support this claim.  Nor did you outline the training reportedly given to the cleanroom personnel.

Your response states you have not observed any test result data discrepancies between your printed versions of the test results.  However, this does not address adequate electronic data controls to prevent inconsistencies between the printed and electronic data.  Your responses for 2A and 2B above are not adequate in that your firm did not provide any corrective action addressing the assessment of all relevant data in the audit trails.

Potential Health Risks

Gerald P. Macedo, OwnerMed-Pharmex, Inc.2727 Thompson Creek RoadPomona, California 91767

The U.S. Food and Drug Administration (FDA) conducted an inspection on January 17, 2017 to February 1, 2017 at Med-Pharmex, Inc., located at 2727 Thompson Creek Road, Pomona, California and determined your firm is a manufacturer of animal drug products such as sterile injectables, oral suspensions, ointments, creams, non-sterile injectable and non-sterile topical ointments.  Our investigators from the FDA identified significant violations of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21 Code of Federal Regulations (C.F.R.), Part 211.  These violations caused your animal drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 351(a)(2)(B), in that the met

Finally, we note that your website at www.medpharmex.com contains the FDA logo with a direct link towww.fda.gov.  The FDA logo is for the official use of the FDA and not for use on private sector materials.  Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.

Regulatory Context

We received your response dated February 22, 2017, concerning the Form FDA 483 (FDA 483), List of Inspectional Observation that was issued to your firm.  We have conducted a detailed review of your firm’s response and note that it lacks sufficient corrective actions for the concerns noted in this letter.

These violations include, but are not limited to, the following:

Your response fails to include any corrective action to ensure that there is no further access or ability to save over test results in(b)(4)spreadsheets once reviewed and approved.