FDAnews Drug Daily Bulletin

Compounding Pharmacy Draws Warning Letter for Misbranded, Unapproved Drugs

Jan. 31, 2017

The FDA Philadelphia district office has issued a warning letter to a compounding pharmacy in Allentown, PA over misbranded drugs and sterility issues.

An FDA investigator inspected Walter’s Pharmacy in March 2016 and discovered the compounder did not have any FDA-approved applications on file for the drug products it promoted.

The inspector also identified a wide-range of deficiencies in the facility’s practices for producing sterile drug products. The firm failed to establish an adequate air supply filtered through high-efficiency particulate air filters and did not have an adequate written testing program for assessing the stability of drug products and to use the results to determine appropriate storage conditions and expiration dates.

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