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Heavy weather in Similasan. The US Food and Drug Administration (FDA) initially imposed a de facto import ban on the Swiss homeopathy manufacturer. Currently 12 products are blacklisted.
Following an inspection of the Jonen AG production facility this spring, the FDA discovered a number of deficiencies in the production process, CH Media newspapers reported. The shortcomings were communicated to the company in an open letter in mid-September. Similasan has 15 days to respond to the allegations.
harsh accusations
The FDA’s claims are serious: Procedures that are supposed to prevent drug contamination are inadequate. Laboratory and quality controls did not meet relevant standards. Additionally, many of the drugs sold are not approved.
The company, around CEO Urs Lehmann (54), popularly known as the President of Swiss Ski, takes a stand on its website. The safety and health of customers were never at risk. Similasan is not aware of any cases that question the safety of its medicines.
Scandal in the USA
Similasan has been operating in the US market since 1987 and has sold over 100 million eye drop packages during that period. It is no coincidence that after more than 25 years of unchallenged commercialization of Similasan, the FDA is now taking action.
In the spring, the United States was rocked by a premium eye drop scandal. Eye drops produced by an Indian manufacturer cost the lives of at least four people and the sight of 14 people. This was because the eye drops were contaminated with resistant bacteria.
Short working hours for employees
FDA hammer a tough setback for Similasan. Similasan’s most important export market is the USA. The company applied for short-time work for employees responsible for the production of products for the American market.
Swissmedic is now also taking action. In response to a request from CH Media newspapers, the Swiss Institute for Therapeutic Goods announced that it was aware of the FDA’s inspection results and warning letter and had clarified the issues. Swissmedic did not want to answer for confidentiality reasons when the last inspection was carried out and whether there were any deficiencies. (ste)
Source :Blick
I’m Tim David and I work as an author for 24 Instant News, covering the Market section. With a Bachelor’s Degree in Journalism, my mission is to provide accurate, timely and insightful news coverage that helps our readers stay informed about the latest trends in the market. My writing style is focused on making complex economic topics easy to understand for everyone.
