16/17 May 2023
In April, the US FDA inspected a manufacturer of OTC products in Mexico. The FDA considered the response letter to the inspection deficiencies found, written five days later, insufficient. Therefore, a Warning Letter followed in October. An import warning had already been imposed on the company in August, preventing potentially dangerous products from being distributed in the USA. Due to the deficiencies found, especially the unacceptable risk of cross contamination, production had to be stopped.
The FDA found during its inspection that pharmaceutical OTC products are manufactured on the same equipment as solutions for the non-pharmaceutical industry. In addition, the company could not provide cleaning instructions. The FDA writes "It is unacceptable as a matter of CGMP to continue manufacturing drugs using the same equipment that you use to manufacture commercial solutions or other non-pharmaceutical products due to the risk of cross-contamination."
The FDA notes that the manufacturer has committed to cease manufacturing medicinal products at this facility and has withdrawn the registration of this manufacturing site. Nevertheless, the agency is requesting a risk assessment for all medicinal products manufactured with said equipment regarding possible cross-contamination, including potential recalls from the market.
Should pharmaceutical manufacturing resume, the FDA expects a plan to show how the manufacturing areas will be segregated and the use of dedicated pharmaceutical and non-pharmaceutical equipment.
The FDA also found deficiencies in the Quality Unit. The responsibilities of the Quality Unit, supplier qualification, batch release, complaints and GMP training were not sufficiently described. In addition, the FDA objected to QC testing of ingredients and the stability programme.
For more details please see the detailed FDA Warning Letter to the Mexican manufacturer Eksa Mills.