FDA warns Spanish drug and API maker of several supply chain issues – Endpoints News


The FDA provided a long list of cited issues to a European manufacturer with production line issues that included microbiological contamination and improper cleaning procedures. Form 483 was sent to the materials manufacturing plant of Spanish pharmaceutical materials manufacturer Bioiberica in Palafolls, north of Barcelona.

During an inspection between January 31 and February 4 of this year, the FDA found that cleaning procedures for equipment used in the manufacture of the drug substance were not validated as necessary to ensure adequate cleaning. and a contamination prevention measure. The FDA also found microbiological contamination and a lack of established control procedures to monitor output manufacturing processes that could potentially lead to drug substance variability.

The factory quality control unit also did not have responsibility for approving all procedures or specifications regarding the identity, strength, quality and purity of substances and did not have a program written test to evaluate stability characteristics.

The FDA found that written records of previous discrepancy investigations did not always include substantiated findings and follow-ups. Inspectors noted that this was particularly problematic around investigations of microbiological nonconformities for an unnamed USP drug.

Bioiberica manufactures a wide range of products for animal, plant and human health. For humans, the company produces glucosamine API, several heparin compounds, and Tendaxion, among a host of other compounds.

This is the first time the company has received a warning from the FDA.


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