NAFDAC blacklists Onifam Laboratories over regulatory violations

NAFDAC, Nigeria's National Agency for Food and Drug Administration and Control, has blacklisted Onifam Laboratories Ltd. due to significant regulatory violations that officials say could jeopardize public health. The decision was announced by NAFDAC Director-General Mojisola Adeyeye during a press briefing in Lagos.

Investigations revealed that Onifam Laboratories engaged in regulatory misrepresentation, including the improper use of approvals and certificates. The company also undermined product traceability and accountability, compromising the integrity of the nation's medicines regulatory system. These actions are in direct violation of the NAFDAC Act and relevant regulations.

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In exercise of NAFDAC’s statutory mandate to regulate and control the importation, manufacture, advertisement, distribution, sale and use of drugs and related regulated products, Onifam Laboratories Ltd. is hereby blacklisted with immediate effect

According to NAFDAC, the company was involved in the misuse of "No Objection" approvals and certificates beyond their intended purpose and conditions. Further investigations uncovered circumvention of regulatory controls through the importation, distribution, marketing, or sponsorship of regulated products in ways that contravened approved NAFDAC processes.

As a consequence, NAFDAC has blacklisted Onifam Laboratories with immediate effect. All individuals and entities associated with the company are barred from applying for, obtaining, renewing, or benefiting from any NAFDAC registration, license, permit, certificate, or approval. They are also prohibited from acting as manufacturers, importers, distributors, agents, consultants, promoters, or marketing authorization holders for any NAFDAC-regulated product. This blacklist remains in force until further directives are issued, and NAFDAC reserves the right to pursue further legal and enforcement actions.

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Through our investigation, we discovered the company is involved in the misuse of approvals and certificates of No Objection outside their approved purpose and conditions, which is misrepresentation.