29 September - 1 October 2020
Because of the GMP deficiencies found during an inspection and the company's unsatisfactory response, the FDA has now issued a warning letter. The main complaints: incoming goods control, release, equipment design and the ventilation system.
The FDA criticised that raw materials had been used in the manufacture of medicinal products without prior quality testing. The release of these substances was based on the supplier's analyses certificates without verifying their validity. Due to the possible contamination that could thus have been overlooked, the FDA now surmises a high risk as far as fatal poisoning for patients.
Another point criticised by the FDA is the release of the drug product. Batches had been released for the market without completion of the batch record review. Batches had been shipped without their microbiological testing being concluded.
The FDA also found defects in the design of the manufacturing equipment. A system the manufacturer had stated was "sterilized" contained dead legs. The FDA believes that the inadequate system design may lead to the development of biofilms. Due to the deficiencies found in the laboratory, which had also been found, the FDA is not convinced that the manufacturer would even notice this. The FDA put the word "sterilized" from the Indian manufacturer's response into inverted commas and speak of "sanitised" themselves at this point.
The HVAC system in the production areas (filling, packaging and storage) is also unacceptable in the FDA's opinion. According to the manufacturer, temperatures in those areas may rise up to 50°C in summer. A control of the humidity, temperature or air cleanness has not been implemented in these areas.
Because of these deficiencies, the FDA doubts the adequacy of the company's own quality unit and suggests they employ a consultant in order to correct the deficiencies found. Especially the materials, laboratory, premises, production equipment and primary quality assurance system should be assessed and improved.
Please see the complete FDA warning letter to the Indian manufacturer Goran Pharma for more detailed information.