FDA Gives 483 To Spanish Drug Ingredient Maker Bioberica
June 21st, 2022 // 3:39 pm @ jmpickett
FDA cited Spanish drug ingredient maker Bioberica with an FDA 483 in May. The drug facility, which is located in Spain, was inspected by FDA inspectors in January and February 2022. During the audit, FDA found several cGMP issues involving improper cleaning procedures and microbiological contamination.
The company was cited with five 483 observations, including poor established control procedures to monitor manufacturing processes output, which could cause drug substance variability.
FDA also was concerned with the poor written records for investigations into earlier discrepancies about a drug that wasn’t named in the report. The written records didn’t reach any conclusions that would mandate follow-up procedures.
Further, Bioberica’s QC unit was cited for specifications or procedures around strength, quality, purity, and identity of drug ingredients and failing to have written testing programs to review the characteristics of stability.
Bioberica makes drug ingredients for human, animal and plant health, its website states. The company produces glucosamine API, Tendaxion for tendon issues, and heparin compounds.
