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NAFDAC seals pharmaceutical company over alleged breaches

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NAFDAC seals pharmaceutical company over alleged breaches

The National Agency of Food and Drug Administration and Control (NAFDAC), on Friday, sealed Gentle Hills Limited, a pharmaceutical company, for alleged production and storage of unregistered products.

The Deputy Director of NAFDAC in Akwa-Ibom, Mr Naeche John, disclosed this during a routine facility visit to pharmaceutical companies in Port Harcourt.

John alleged 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.

He said that the agency once visited the company on a facility check to ensure it was operating in line with GMP.

“GMP is a controlled system to ensure that products are consistently produced and controlled in quality standard expected of a particular product,” John said.

He alleged that the agency was refused the check before it went back to the company with regulatory force agents to be able to access the facility.

“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.

“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,” he said.

He further alleged that Anyanwu claimed to have contract with a manufacturing company that produced for them but that company’s name was not on the labels and packages, rather it Gentle Hills Ltd that was on the packaging as the manufacturer.

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“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,” John said.

Reactung to the allegations, Anyanwu said that his company had NAFDAC approved numbers for the production of some products.

According to him, the old packaging materials and bottles seen by NAFDAC officers in the company’s stores were moved from the company’s old site.

“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,” he said.

Anyanwu also insisted that the company notified NAFDAC about the errors on the address and was advised by the agency to correct the errors.

NAFDAC seals pharmaceutical company over alleged breaches

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