FDA Enforcement News

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 [...]

14 09, 2017

FDA Issued 66 Product Recalls, Import Alerts, and Consent Decrees in August 2017

By | 2017-11-27T16:31:45+00:00 September 14th, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Enforcement News, FDA Inspections, Medical Devices|

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! […]

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. [...]

22 08, 2017

US-EU Mutual Recognition Agreement of 2017

By | 2018-02-16T13:19:13+00:00 August 22nd, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, Medical Device - Featured, Medical Devices, quality assurance|

A Long Time in the Works by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Implementation of the Mutual Recognition Agreement (MRA) for drug GMP inspections between the US FDA and the European Union (EU) inspectorates has been in the development since 1998 and was formalized this year. This agreement was driven by [...]

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): [...]

30 04, 2016

Does an FDA Import Alert automatically equate to an impending FDA Warning Letter?

By | 2018-02-14T12:10:07+00:00 April 30th, 2016|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices, MOST POPULAR|

by Barbara Unger, FDAzilla GMP Quality Expert INDIA | IMPORT ALERT 66-40 and Association with Warning Letters Regarding These Sites | Detention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs  […]

14 05, 2015

PRESS RELEASE: New Data Provides FDA-Regulated Industries Unprecedented Insights Into FDA Inspection Trends and Enforcement Actions

By | 2016-07-08T14:02:19+00:00 May 14th, 2015|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, Form FDA 483|

CHICAGO, IL – May 14, 2015 Today, FDAzilla unveiled Enforcement Analytics, a ground-breaking data analytics tool that gives industry greater insights into FDA enforcement actions and inspection activity.  For the first time in the industry, data on FDA inspections, FDA inspectors, Form 483s, manufacturing sites regulated by the FDA, and FDA warning letters are all linked together, creating huge potential for [...]