The Spanish Agency of Medicines and Medical Devices (AEMPS) made the comments in a document posted on the EudraGMDP database today, explaining that the proposed corrective measures lack detail.
“In general the proposed corrective actions were insufficient, diffuse and do not provide a description about the extent of the measures, so to ensure the correction of the major deficiencies.
“In particular, those related to the lack of personnel remain unsolved, and the accumulation of tasks and responsibilities in some personnel is a risk to quality” AEMPS continued, adding that the remediation plan does not address the site's lack of a quality control lab.
The good manufacturing practice (GMP) deviations were observed by an AEMPS team who visited the facility in June.
At the time, the investigators said “the company [Alcor] does not have suitable facilities, personnel and materials resources to ensure proper compliance.”
No recall required
The Guadalajara facility produces a oral antibiotic called Denticelso, a combination of tyrothricin and acetilsulfamida sodium, for the Spanish market.
It also makes a laxative called Jarabe del Dr Manceau.
AEMPS recommended a temporary suspension of activities, but did not insist that products made at the site were recalled.
It said: "Manufacturing activities are limited; no specific quality defects have been identified that need any market action. A recall is not considered to be necessary."