31 01, 2018

FDA Sent These 4 Warning Letters for Medical Device Companies | Oct – Dec 2017

By | 2018-02-16T13:02:40+00:00 January 31st, 2018|CGMP, FDA Enforcement Trends, FDA Warning Letters, Medical Device - Featured, Medical Devices|

We took a snapshot of the 4 warning letters the FDA sent to medical device companies last quarter.  Device manufacturing violations ranged from failing to evaluate complaints to failing to establish procedures for quality audits. From device manufacturers in India, Lithuania, and more, here they are (starting with the most recent): […]

25 01, 2018

If You Didn’t Document It, It Didn’t Happen

By | 2018-02-12T14:49:02+00:00 January 25th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDAzilla, Medical Device - Featured, Medical Devices|

A Guest Post from Oliver Yu, CTO, FDAzilla A core belief of drug manufacturing is that the drug alone is not the product of the pharmaceutical company.  The drug and the documentation proving that the drug was made properly is the output of the pharmaceutical company.  This belief is at the core of data integrity.  If you think about it, [...]

11 01, 2018

The End of Homeopathic Products’ Free Pass

By | 2018-02-12T14:35:05+00:00 January 11th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, Pharma - Featured|

Homeopathic Products:  What Are They and Why Should You Care? by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Among the unique enforcement actions in fiscal year 2017 are a cluster of warning letters and recalls of homeopathic products.  2017 saw as many warning letters issued to these firms as were issued between 2009 and 2013.  This is a [...]

10 01, 2018

Is the FDA Now Shifting its Focus to South Korea?

By | 2018-01-13T01:21:42+00:00 January 10th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

FDA Enforcement Actions Against Firms in South Korea by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Several years ago, the FDA began, in earnest, to take more enforcement actions against sites outside the US than they did against sites within the US.  This was simply because the majority of drugs and APIs are produced outside the US.  If we [...]

22 12, 2017

Novel Medicinal Products Part II (The EMA’s Guidance)

By | 2017-12-30T01:41:25+00:00 December 22nd, 2017|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends|

The EMA and GMPs for Advance Therapy Medicinal Products by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Manufacturing and testing of Advance Therapy Medicinal Products (ATMPs) is generally significantly different from processes used in chemical synthesis of small molecules or cell-based production of recombinant DNA therapeutic products.  The novelty and complexity of these new products prompted the [...]

21 12, 2017

Novel Medicinal Products Part I (The FDA’s Guidance)

By | 2017-12-30T01:02:10+00:00 December 21st, 2017|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends|

The FDA and Its New Guidance on Regenerative Medicine Drugs by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief The four guidance we address here are part of the FDA’s announced ‘comprehensive regenerative medicine policy framework’ and support implementation of provisions in the 21st Century Cures Act.  The FDA is actively supporting the development of stem cell and [...]

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. [...]