16-18 November 2021
In March 2018, the FDA has issued a Warning Letter to a manufacturer of medicinal products in the Dominican Republic due to various GMP violations. The starting point had been an FDA inspection conducted in June 2017. The manufacturer had commented on the deficiencies found during the inspection in July 2017. However, the FDA found the response inadequate, as the now issued Warning Letter shows. The following issues were criticised:
The FDA sees a great cross contamination risk since different production facilities had not been separated from each other. The document doesn't explicitly say so, but it can be derived from the information that beta-lactam and non-beta-lactam production facilities were concerned. The FDA demands a risk assessment of possible cross contamination for all batches distributed in the USA. Moreover, the FDA recommends the dedication of the production facility, presumably for manufacturing beta-lactam. If the company wishes to continue the production of non-beta-lactam, the whole facility must be decontaminated, which should prove to be quite difficult in the FDA's opinion. A dedication to this product class will then also be necessary.
Another point of compliant was the insufficient data integrity of laboratory results. The FDA criticises that not all analyses data is stored, making it impossible to comprehend in hindsight which analysis method had been used and whether the results are valid. In this instance, the FDA also requires a risk analysis for all lots distributed in the USA.
It was also criticised that some test methods had not been validated. This included API testing as well as the test method for the finished pharmaceuticals. Furthermore, the FDA determined that laboratory equipment had not been qualified, thereby casting the validity of test results into doubt.
Because of the severity of the deficiencies, the FDA recommends the company to engage a GMP consultant to eliminate all defects.
For further details please see the FDA's Warning Letter to Labocont Industrial SRL.