FDA Inspections

25 09, 2017

The Heightened Importance of Contract Manufacturing Organizations

By | 2017-11-27T11:26:41+00:00 September 25th, 2017|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief One of the most thought-provoking presentations at the recent PDA / FDA meeting in Washington DC was given by Guy Villax, CEO of Hovione Pharmaceuticals.  Hovione Pharmaceuticals offers a range of contract services including but not limited to, product development, manufacturing of API and drug products, and analytical support. [...]

25 09, 2017

New FDA GMP Inspection Model

By | 2018-02-14T11:48:18+00:00 September 25th, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, Inspection - Features, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted.  The FDA recently made available a description of their new operating model that will ensure integration of review and inspection [...]

23 08, 2017

Summer Enforcement Actions for Compounding Pharmacies and Outsourcing Facilities

By | 2017-12-01T22:02:49+00:00 August 23rd, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief July and early August 2017 saw another uptick in FDA actions associated with compounding pharmacies/outsourcing facilities.  In the past few years, the FDA has placed a disproportionate effort towards enforcement actions for these facilities.  We have addressed this focus and the history of these facilities in a previous blog. [...]

16 08, 2017

FDA Sent These 9 Warning Letters for Pharma Companies | July 2017

By | 2017-12-01T22:06:04+00:00 August 16th, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Inspections, FDA Warning Letters, quality assurance|

We took a snapshot of the 9 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “adulterated and misbranded drug products” to sites “failing to sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination.” From pharmaceuticals in Italy, Tennessee, and more, here they are (starting with the most recent): [...]

21 07, 2017

CHINA DRUG INSPECTIONS, 2016

By | 2017-11-06T01:19:57+00:00 July 21st, 2017|Biopharma / Pharma, FDA Inspections, FDAzilla, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief China published their annual report of drug inspections for 2016 on June 2, 2017.  The 31-page document reports on a variety of inspection types including but not limited to: pre-approval inspections, GMP certification inspections, and GMP follow-up inspections.  The report is accompanied by tables and figures.  For the most [...]