Spain’s medicines and medical devices agency suspended manufacturing at Euro Far Alergi’s Madrid facility citing serious GMP violations. Read More
FDA served Porton Biopharma a warning letter after an inspection revealed failures to notify the agency of changes affecting drugs, and failing to follow procedures to prevent microbiological contamination. Read More
The Oxygen Therapy Institute was hit with a Form 483 for inadequate acceptance procedures, calibration procedures, and other deficiencies. Read More
Germany’s Biotronik received a warning letter for inadequate process validation procedures, supplier selection procedures, and other violations. Read More
The FDA has served drug manufacturer Eisai Inc. with a Form 483 after an investigation revealed laboratory control issues and incomplete records. Read More
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