Warning Letter for not meeting FDA/USP Requirements

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Wild Child WA Pty Ltd., that summaries three significant GMP issues identified during a 5-day inspection of the company's manufacturing facility in Malaga, Western Australia. The core issue is the non-compliance with requirements specified in the United States Pharmacopeia (USP).

Release without adequate Testing

According to the FDA, Wild Child WA Pty Ltd released finished over-the-counter (OTC) drug products for the U.S. market without adequately testing the identity and strength of the active ingredient. For release testing, methods (e.g. residue on ignition) were used which are inferior to the method established in the corresponding USP monograph. The company's argument that quantitative chemical tests were not performed because the Australian GMP license allows to perform physical testing only, was not accepted by the FDA.

No adequate written Procedures for Production and Process Control

The FDA also states that the company does not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. Furthermore, there was no documentation available showing that certain manufacturing processes had been validated.

Inadequate Identity Testing

The third issue listed in the warning letter concerns the test of incoming components for identity which were used to produce the OTC drugs intended for U.S. distribution. Wild Child WA Pty Ltd stated that individual testing of excipient components is not mandated in Australia for the OTC product concerned and that inactive ingredients were accepted based on the supplier's certificate of analysis (COA).

In a response to a form FDA 483, that preceded the warning letter, Wild Child WA Pty Ltd indicated that a Fourier Transform Infrared (FTIR) instrument would be purchased to implement identification testing for each ingredient. However, this response was not sufficient for the FDA because no documentation or timeline was provided to indicate when identity testing of components used in U.S. drug products would begin.

Conclusion

The FDA strongly recommends engaging a consultant to assist the company in meeting CGMP requirements. Wild Child WA Pty Ltd. has 15 working days to respond to the FDA in writing. Failure to correct the violations may result in the FDA refusing admission of articles manufactured at the facility in Malaga into the United States.

This warning letter shows once again how important it is to be in line with the FDA's current compliance requirements. If a company wants to supply the american market, not only the local requirements for analytical testing but also the requirements established in USP must be strictly met. Drug products distributed to the U.S. market must be manufactured and analysed in accordance with U.S. drug regulations.

The original warning letter to Wild Child WA Pty Ltd. can be found on the FDA website.