The National Agency of Food and Drug Administration and Control (NAFDAC) has sealed a pharmaceutical company, Gentle Hills Limited, for alleged production and storage of unregistered products.
The Deputy Director of NAFDAC in Akwa-Ibom State, Naeche John, made this known during a routine facility visit to pharmaceutical companies in Port Harcourt, the Rivers State capital, on Friday.
John disclosed that the affected company was producing some products without NAFDAC registered numbers
“The practice is not in line with NAFDAC Good Manufacturing Practice (GMP) regulations,” he said.
John said the agency once visited the company on a facility check to ensure it was operating in line with GMP, adding: “GMP is a controlled system to ensure that products are consistently produced and controlled in quality standard expected of a particular product.”
He stated that the agency was denied the check before it went back to the company with regulatory force agents to be able to access the facility.
John said: “We saw that the company has some packaging materials and finished products which were not registered by NAFDAC, while about twelve product packages and labels had the same NAFDAC number, which is not supposed to be.
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“The Managing Director of the company, Mr Nnamdi Anyanwu, claimed he had yet to start production at the company’s new site.
“But we saw some finished products and evidence of production in the factory without evidence of approved registered numbers of the agency.
“We saw different brands of cough syrup packages, such as quinykid syrup, pundy suspension, Mist Alba, flush quick action, chestalyn, sprilyn, spirex, containers for production, biological test tubes, among others.”
The NAFDAC deputy director further alleged that Anyanwu claimed to have a contract with a manufacturing company that produced for them but that company’s name was not on the labels and packages, rather Gentle Hills Ltd was on the packaging as the manufacturer.
John added: “The managing director also claimed to have reported to NAFDAC about the errors made on the labels and packages of the manufacturer’s address by the printer.
“We urge him to bring a copy of the letter he submitted notifying NAFDAC of the errors to our office.
“All these abnormalities speak volume about the standard of the products manufactured in the company not in line with the GMP regulations.
“We have invited the management of the company to our office for sanction.”
Reacting to the allegations, Anyanwu said his company had NAFDAC-approved numbers for the production of some products.
He said the old packaging materials and bottles seen by the agency’s officers in the company’s stores were moved from the company’s old site.
He said: “We do not intend to make any product without NAFDAC registration number and we have never made any without approval.
“We are still waiting for the registration numbers after proper documentation at NAFDAC.”
Anyanwu added that the company notified NAFDAC about the errors in the address and was advised by the agency to correct the errors.
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