FDA Inspections

22 02, 2018

5 Ways Manufacturing Quality Problems Can Take Down a Company

By | 2018-02-22T17:26:09+00:00 February 22nd, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, FDA-Regulated Industry, Food, Form FDA 483, Medical Devices|

Manufacturing quality issues arise from time to time at pharmaceutical, medical device, and food companies, and if left unchecked, can lead to massive losses. Analyzing FDA inspections and a company's performance provides early insights into any potential issues that may be brewing. Almost all quality-related warning letters start with an inspection and a 483. While some warning letters result [...]

19 02, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 2/11/18

By | 2018-02-19T15:16:07+00:00 February 19th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Inspections, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers The week of February 11, 2018 was slow in the publication of guidance documents. The FDA published three, and the EMA did not publish any in the areas we follow. Health Canada and HPRA each published one item. There were also non-guidance documents and information published by EMA, MHRA, and FDA. To see [...]

9 02, 2018

The Ultimate Guide to Researching Your FDA Inspector

By | 2018-02-16T13:24:46+00:00 February 9th, 2018|Biopharma / Pharma, CGMP, FDA, FDA Enforcement Trends, FDA Inspections, FDA-Regulated Industry, FDAzilla, Food, FSMA, Inspection - Features, Medical Devices, Pharma - Featured|

The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably busy with a million things on your to-do list.  And while you know you should set up a complete FDA inspection preparedness program, you just [...]

18 01, 2018

FDA Issued 42 Product Recalls, Import Alerts, and Consent Decrees in December 2017

By | 2018-02-16T22:37:46+00:00 January 18th, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Enforcement News, FDA Inspections, FDAzilla|

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

13 10, 2017

FDA Issued 36 Product Recalls, Import Alerts, and Consent Decrees in September 2017

By | 2017-11-27T11:21:48+00:00 October 13th, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Enforcement News, FDA Inspections, FDAzilla, Medical Devices|

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

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. [...]