How WHO regulations forced FDA to suspend Tobinco’s Entrance Pharmaceutical from production
Published:
3 months ago
Source:
GhanaWeb
The seeming feud between the Food and Drugs Authority (FDA) and Tobinco Pharmaceuticals Ltd. continues as a new document sighted by shows that the authority directed a subsidiary of the company to shut down its operations this year, 2024. A letter addressed to the Managing Director of Entrance Pharmaceutical and Research Centre, a subsidiary of Tobinco, which was issued by the Chief Executive Officer, Dr. Delese Darko, shows that the authority directed the closure of the company, citing violations of World Health Organization (WHO) guidelines for Good Manufacturing Practices. The letter indicated that the violations by Tobinco's subsidiary were very serious and involved "39 major" and "5 other" deficiencies of WHO guidelines at the manufacturing plant of Entrance Pharmaceutical, which were sighted during an inspection by officials of the FDA.
"Following the routine inspection of your facility located at 16 Okpoi Gonno Light Industrial Area, Accra, by the Food and Drugs Authority from June 24 to June 26, 2024, to ascertain the level of compliance with Good Manufacturing Practices (GMP), certain deficiencies were observed.
"The deficiencies, which have been categorised into 5 "critical," 39 "major," and 5 "other" deficiencies, have rendered the facility non-compliant with the WHO guidelines for good manufacturing practices.