23 Feb SAHPRA Responds to Carte Blanche Report on Alleged GMP Non-compliance at Adcock Ingram Clayville Facility
The South African Health Products Regulatory Authority (SAHPRA) has noted the recent Carte Blanche broadcast raising concerns, based on information from a former employee, regarding alleged Good Manufacturing Practice (GMP) non-compliance at Adcock Ingram’s manufacturing facility in Clayville, Johannesburg.
SAHPRA wishes to assure the public that all allegations relating to possible regulatory infringements or risks resulting from non-compliance to GMP that compromise product quality and patient safety are treated with the utmost urgency. SAHPRA is mandated by the Medicines and Related Substances Act 101 of 1965, as amended, to ensure that medicines meet required standards of quality, safety, and efficacy.
SAHPRA confirms that it conducted several GMP inspections at the Adcock Ingram Healthcare Clayville site between August 2023 and October 2024. The inspections focused on sterile eye drops and oral dosage forms as part of routine regulatory inspections.
During the August 2023 inspection, corrective and preventive actions (CAPAs) were identified, which upon a verification inspection in June 2024 the sterile manufacturing section was found compliant with all prior CAPAs and satisfactorily closed.
Some non-compliances were, however, identified in the oral dosage forms section of the manufacturing facility, following which the manufacturer voluntarily halted production in the areas highlighted in Liquids, Powders and Tablets. A further inspection in October 2024 assessed these interventions and based on the evidence submitted and corrective measures implemented, SAHPRA was satisfied that appropriate remedial actions had been taken and that the necessary standards to safeguard public health were met and granted a GMP licence in March 2025.
On 16 April 2025, SAHPRA received a complaint about unhygienic conditions at Adcock Ingram Clayville. Attempts to contact the complainant failed. On 22 April 2025, inspectors conducted an unannounced inspection, reviewed Citro Soda Batch Manufacturing Records, and inspected the secondary packaging room previously affected by wastewater discharge. Microbiological tests for possibly impacted products and the room were negative for contamination. Inspectors found cleaning logs lacked cleaning times and instructed the company to update them for campaign batches.
SAHPRA remains firmly committed to transparency, accountability, and protecting patients. Members of the public or industry stakeholders with credible information regarding possible non-compliance are encouraged to submit such information through SAHPRA’s official reporting channels, where it will be assessed through formal regulatory mechanisms.
