Pest Control - Warning Letter to US Company

In recent weeks and months, there has been much discussion about the requirements of the new Annex 1, including the topic of the contamination control strategy and what it should cover. Everyone has been discussing microbiological monitoring, disinfection measures, whether cleaning validation of the systems is part of this and much more.

Now a US company has received a Warning Letter that deals with an issue that often receives only marginal attention as the first point of non-compliance. It states: "Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a))."  While the invisible threat of bacteria and fungi is often discussed in detail in the guidelines, the topic of pest control is often marginalised with the view that it is "outsourced".

In this Warning Letter to Omeza, in addition to mould-like deposits in the air conditioning system, the complaint also refers to contamination with live and dead insects and other animal waste in the sampling and product storage area. Although Omeza had responded to the complaints with corrective and preventive actions (CAPA) to implement a pest control programme and had also conducted an investigation by an outside consultant for the mould-like substance on the air conditioning unit shell, the resulting response was insufficient for the FDA. The FDA lacked review of environmental monitoring data from the manufacturing process and adequate risk analysis of previously manufactured drug products and testing of retained samples of affected batches.

The second section of the Warning Letter criticises the lack of incoming inspection of the components used and also the fact that components were accepted from suppliers whose analysis had not been checked for validity: "You failed to adequately test your incoming components for identity before using the components in your drug products. Additionally, your firm accepted components from suppliers without establishing the reliability of your suppliers' test analyses." The letter further stated: "For example, you failed to perform identity testing of at least one lot of cod liver oil used to manufacture your skin protectant and lidocaine lavage drug products. In addition, the supplier qualification records for the lidocaine used in your lidocaine lavage drug products did not include initial or routine analysis to establish reliability of the supplier's certificate of analysis (COA)."

The third deviation addressed was an inadequate stability test and the associated failure to establish appropriate storage conditions and expiry dates based on these results in accordance with 21 CFR 211.166(a). Stability data from another product was also used to determine an expiry date.

In addition, topics such as false claims, lack of authorisation and brand protection are also part of the Warning Letter. Further details can be found directly in the FDA Warning Letter.