Medical Device – Featured

///Medical Device - Featured
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, [...]

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 [...]