The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Limited, its Managing Director, members of its board of directors, and all affiliated individuals or entities found to have participated in regulatory violations.
The decision was announced in a statement issued by the Director-General of NAFDAC, Prof. Mojisola Adeyeye, following investigations that uncovered multiple breaches of the agency's regulatory framework.
According to NAFDAC, the investigation revealed cases of regulatory misrepresentation, misuse of the agency's approvals and certificates, improper registration and transfer of pharmaceutical products, as well as other activities carried out outside established regulatory procedures.
The agency said the violations compromise product traceability, weaken regulatory accountability and pose significant risks to public health.
As a result, all affected persons and entities have been prohibited from participating, either directly or indirectly, in any pharmaceutical business regulated by NAFDAC.
The blacklist bars them from applying for registrations, licences, permits, certificates or other regulatory approvals. They are also prohibited from operating as manufacturers, importers, distributors, marketing authorisation holders, consultants, agents, promoters or sponsors of products regulated by the agency.
NAFDAC stated that the sanctions take immediate effect and will remain in force until further notice.
The agency added that further regulatory, administrative and legal actions may be taken against the affected individuals and entities where necessary.
Reaffirming its commitment to safeguarding public health, NAFDAC said it would continue to strengthen regulatory enforcement to protect Nigerians from substandard and falsified medicines.
The agency also urged stakeholders across the pharmaceutical sector to strictly comply with all applicable laws, guidelines and regulatory standards to ensure the safety, quality and integrity of medicines and other regulated products.
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