FDA Issues Warning Letter to Repackaging Facility

FDA issued a warning letter on April 7, 2016 to Apotheca Supply, Inc. dba Apothecares, a company located in Decatur, Alabama that repackages and relabels pharmaceuticals. The warning letter was in response to the company’s lack of a proper response to citations found during a February 2015 inspection. The company was cited for failure to ensure cleanliness of equipment, a lack of stability data, and failure of the quality unit to approve procedures.

In the warning letter, FDA said that an inspection found that standard operating procedures (SOPs) were not approved by the company’s quality unit. The quality unit had also not reviewed or approved quality-related documents, batch records, certificates of analysis (CoAs), and the extension of API expiration dates.

FDA stated the company must “conduct a risk assessment and provide us with a summary of the risks your deviations posed to the quality of your API. Include in your risk assessment all API within expiry that were repackaged and distributed within the United States. Evaluate the product batch records and CoAs not approved by your quality unit and address them in your risk assessment. Ensure each CoA you generated contains accurate information. Also, provide adequate justification for your risk assessment. Provide your plan for ensuring continuous compliance with your annual product quality review procedure. It is your responsibility to adhere to procedures established at your facility and commitments made in your correspondence to the FDA. Additionally, provide an organizational chart that specifies the personnel authorized to release API and provide evidence that quality unit personnel are adequately trained in current good manufacturing practice.”

The FDA inspection also found the company failed to ensure the cleanliness of the facility and equipment. Investigators observed expired cleaning products and operators using cleaning agents not documented in cleaning procedures. The company also failed to perform cleaning validation studies. FDA stated in the letter, “This CGMP deficiency is similar to one we found during our January 2010 inspection. In your response, you state you are developing a cleaning validation program to evaluate the effectiveness of your cleaning process. In response to this letter, provide your cleaning validation protocol, the timeline for its execution, and your justification of its effectiveness for the various drugs you repackage and cleaning procedures you use. Provide your process for ensuring that no unapproved cleaning agents will be used in your facility.”

Source: FDA