Tuesday, 12 December 2023 14.00 - 16.00 h
FDA Warning Letters are of enormous importance for pharmaceutical companies. This is once again demonstrated by the case of a Swiss company that received a Warning Letter on September 11, 2023.
According to reports in the Swiss media (including the Swiss broadcast and radio station SRF - in German language only), the Warning Letter led to a 90% loss of sales in Similasan's US business. During an inspection by the FDA, the FDA inspectors first noted violations of the GMP regulations, which are defined in 21 CFR 210 and 211, on the 483 form. During the subsequent review of the deviations, the FDA assessed how serious the deviations were and whether further measures are required. In serious cases, the FDA issues a Warning Letter, which can then be followed by an import ban in the USA for the establishments and medicinal products concerned.
We have already reported in detail on the FDA Warning Letter to the company and the GMP deviations listed therein in our GMP News on 2 November 2023. The product in question is eye drops, which are under special observation by the FDA, as there have been quality problems here in the past (with products from other companies).
CONCEPT HEIDELBERG analyses the FDA Warning Letters annually and reports on them in the GMP Journal. For example, you will also find the article "The most Frequent GMP Deficiencies in Quality Control" and other articles on FDA Warning Letter analyses.
A comprehensive analysis of all GMP Warning Letters of the last fiscal year (ending in September) will be published in the GMP Journal shortly. If you are interested, you can subscribe to the GMP Journal newsletter here.