FDA warns Spanish drug and API manufacturer over multiple production line problems
The FDA delivered a laundry list of cited problems to a European manufacturer with production line issues that included microbiological contamination and improper cleaning procedures. The Form 483 was sent to Spanish drug materials manufacturer Bioiberica’s materials manufacturing plant in Palafolls, north of Barcelona.
In an inspection between Jan. 31 and Feb. 4 this year the FDA found that cleaning procedures for the equipment used in the drug substance manufacturing were not validated as necessary to ensure adequate cleaning and contamination prevention measure. The FDA also found microbiological contamination and a lack of established control procedures to monitor the output manufacturing processes that could potentially cause variability in the drug substance.
The plant’s quality control unit also lacked the responsibility to approve all procedures or specifications around identity, strength, quality and purity of substances and had no written testing program to assess the stability characteristics.
The FDA found that written records of investigations into previous discrepancies didn’t always include conclusions and justified follow-ups. The inspectors noted that was particularly problematic around investigations of microbiological non-conformities 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 slew of other compounds.
This marks the first time the company has received a warning from the FDA.