The National Agency of Food and Drug Administration and Control (NAFDAC), has sealed off Gentle Hills Limited, a pharmaceutical company, for the alleged production of unregistered cough syrup in Port Harcourt, Rivers state capital.
Naeche John, a deputy director of NAFDAC, said the company was carrying out production without NAFDAC registration numbers.
He said the agency previously visited the company on a facility check to ensure it was operating in line with good manufacturing practices but was denied access.
Subsequently, “on the use of regulatory force”, NAFDAC said it discovered that the company’s products either had no registration number or one number was used for several products.
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“The practice is not in line with NAFDAC Good Manufacturing Practice (GMP) regulations,” John said.
“GMP is a controlled system to ensure that products are consistently produced and controlled in the quality standard expected of a particular product.
“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 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.
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“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.”
Nnamdi Anyanwu, managing director of the pharmaceutical firm, said his company had NAFDAC-approved numbers for the production of some products.
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He said the old packaging materials and bottles seen by NAFDAC officers in the company’s stores were moved from an old site.
“We do not intend to make any product without NAFDAC registration number and we have never made any without approval,” he said.
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“We are still waiting for the registration numbers after proper documentation at NAFDAC.”
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