Finnish authorities have ordered the immediate suspension of operations at an aesthetic clinic in Espoo after inspectors found unlicensed medicines, improper storage practices and failures in patient care standards.
The supervisory authority said it carried out an unannounced inspection at Nordicshape Oy on 8 April alongside the Finnish Medicines Agency and the Safety and Chemicals Agency. The inspection followed a report from Fimea that raised suspicion over the import and use of an unlicensed botulinum toxin product.
Inspectors said they found medicines without marketing authorisation and products labelled as cosmetics that contained active pharmaceutical ingredients such as anaesthetics. “Premises contained unlicensed medicines and products with medicinal substances despite cosmetic labelling,” said Heidi Staudinger, senior inspector at the authority.
Officials stated that the use of such products posed a serious risk to patient safety because their contents could not be verified. They also reported that medicines were stored in unlocked areas without temperature monitoring, and that expired drugs had been used in patient treatments.
The authority said botulinum toxin procedures at the clinic took place without proper medical oversight. Under Finnish rules, such treatments require a doctor’s prescription and supervision, including availability during the procedure due to risks such as muscle paralysis that can affect breathing.
Inspectors also raised concerns about staff qualifications. They said they did not receive proof that practitioners administering injections had completed required training. Documentation requested during and after the inspection was not provided, according to the authority.
Medical devices used at the clinic lacked proper markings or records of maintenance. Officials said they could not confirm whether the equipment met requirements for patient use.
The authority ordered an immediate halt to healthcare services at the Espoo site and described the decision as permanent, subject to appeal.
Reporting by Helsingin Sanomat revealed that the decision triggered a wave of resignations among staff and contractors. The outlet said the number of listed nurses dropped sharply within hours of the case becoming public.
The clinic’s chief executive Samuel Rossi disputed key findings. He told Helsingin Sanomat that claims of botulinum toxin use were false and originated from a former employee. He also denied that expired medicines had been administered, stating that some products remained on site past their dates due to accounting procedures.
Rossi said the company had since installed a lock on its medicine storage and added temperature monitoring equipment. He described the situation as a reputational issue that led to staff departures.
According to Yle, another owner, Taina Heikkinen, said the company had obtained products from a South Korean manufacturer that had assured compliance with regulations. “This was a great surprise. This is a serious situation and I am sorry this has happened,” she told the broadcaster.
Heikkinen denied importing illegal botulinum toxin and said products with incorrect labelling had been removed from use. She added that the company would review equipment markings and other deficiencies identified by inspectors.
Authorities said they found no direct evidence of the specific botulinum toxin product cited in the initial report, but noted strong suspicion based on interviews conducted during the inspection.
The suspension applies to the Espoo clinic in Leppävaara. The company operates another site in Helsinki, which continues to offer services not classified as healthcare treatments. The authority did not comment on that location.
Officials stated that as a healthcare provider, Nordicshape bears full responsibility for ensuring safe and compliant operations. They said the deficiencies identified posed a direct threat to patient safety and justified immediate action.
HT
