Italian firm warned by FDA over record-shredding and drug quality misrepresentation
Italian drug manufacturer FACTA Farmaceutici has been issued a warning letter by the FDA after being found shredding “critical laboratory and production records” and conducting suspicious data integrity protocols by storing original data in unauthorised spreadsheets and computer drives.
A range of violations of Good Manufacturing Practice (GMP) were found by the FDA following an inspection of the Teramo, Italy facility in September 2014.
Of particular concern were the company’s practices concerning the storage and presentation of crucial product data; the FDA found that records for multiple sterile drug products were stored on an “‘unofficial’ and uncontrolled electronic spreadsheet on a shared computer network drive” and when it enquired about the practice, was assured by an analyst from the company that the data was later transcribed to an ‘official’ form.
Inspection of the recorded data revealed the failure of these sterile drug products to meet adequate ‘Visible Particle Determination’ standards, contrary to the results reported by the company which indicated that the products had passed with acceptable levels.
The FDA has called on FACTA to conduct an investigation on its recording and reporting processes as well as a risk assessment on the potential dangers posed by its failures in quality control.
Karuna Therapeutics has announced that it has submitted a New Drug Application (NDA) to the …
Regeneron Pharmaceuticals and Sanofi have announced that the US Food and Drug Administration (FDA) has …