AEMPS (Spanish Agency of Medicines and Medical Devices) detailed its concerns in a EudraGMDP filing published today.
Inspectors identified deficiencies in manufacturing quality systems during an inspection of the site in Leganes near Madrid, Spain in November.
The agency said: “Critical and mayor deficiencies detected on the last inspection carried out on 16-17/11/16 impact on the quality system of the site and the manufacturing process of inmunological medicinal products.”
Critical deficiencies included the “lack of an effective pharmaceutical quality system” and the fact the firm released batches of bacterial vaccines without performing sterility checks or process validation.
AEMPS also said: “Validation of inactivation process for bacterial vaccines and bacterial auto-vaccines is not performed. Thus, the quality of the products manufactured by this site cannot be assured.”
Laboratorio Angulema makes subcutaneous sterile bacterial vaccines, subcutaneous sterile bacterial auto-vaccines and subcutaneous sterile allergenic vaccines, primarily for the Spanish market.
AEMPS temporarily suspended the firm’s manufacturing and importation authorisations (MIA).