Medical Devices

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 [...]

17 08, 2017

FDA Issued 48 Product Recalls, Import Alerts, and Consent Decrees in July 2017

By | 2017-12-01T22:04:58+00:00 August 17th, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Consent Decree, FDA Inspections, Medical Devices, quality assurance|

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

27 07, 2017

FDA issued 39 Product Recalls, Import Alerts, and Consent Decrees in June 2017

By | 2017-11-06T03:18:15+00:00 July 27th, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Inspections, Medical Devices|

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

21 06, 2017

FDA issued 47 Product Recalls, Import Alerts, and Consent Decrees in May 2017

By | 2017-11-06T01:19:57+00:00 June 21st, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Inspections, Medical Devices|

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

13 06, 2017

The FDA Re-Org Has Begun. What Does it Mean for You?

By | 2017-09-15T21:58:53+00:00 June 13th, 2017|FDA, FDA Inspections, FDAzilla, Medical Devices, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief BACKGROUND: The FDA began a plan to align the Office of Regulatory Affairs (ORA) into a ‘program based structure’ in 2013.  This reorganization is now being implemented. The ORA is the lead for all FDA field activities including inspections of regulated products and their manufacturers, and review of imported [...]

30 06, 2016

5 FEATURES TO LOOK FOR IN A WARNING LETTER

By | 2018-01-26T23:25:53+00:00 June 30th, 2016|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Inspections, FDAzilla, Food, Form FDA 483, Medical Devices, quality assurance|

5 FEATURES TO LOOK FOR IN A WARNING LETTER Warning letters are the FDA’s second level of enforcement actions after issuance of a form 483. The FDA determined that either the firm’s response to the form 483 was inadequate or the observations were serious enough to support issuance of a warning letter.   Often it is possible to determine the corrective actions [...]

16 06, 2016

5 FEATURES TO LOOK FOR IN AN FDA FORM-483

By | 2018-01-26T23:21:30+00:00 June 16th, 2016|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Inspections, FDAzilla, Food, Form FDA 483, Medical Devices, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief A form-483 is the document that the FDA issues at the close of an inspection where they identify observations made during the inspection.  If no observations are made, no 483 is issued.  Based on the response submitted by the firm, the FDA classifies the inspection as:  No Action Indicated [...]

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  […]

25 03, 2015

We Learned 5 Things from 2014 FDA and EU GMP Drug Enforcement Actions

By | 2017-11-06T01:19:57+00:00 March 25th, 2015|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Consent Decree, FDA Inspections, Form FDA 483, Medical Devices|

2014 proved to be another busy year for the FDA.  We asked Barbara Unger, President of Unger Consulting and Editor-in-Chief of GMP Regulatory Intelligence, to summarize her key take-aways from the enforcement actions of the FDA and EU in 2014. Here’s Barbara: […]