cGMP Quality Assurance and FDA 483s

/cGMP Quality Assurance and FDA 483s
23 02, 2018

Week of Feb 11th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

By | 2018-02-23T16:23:36+00:00 February 23rd, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDAzilla|

The FDA posted 6 warning letters this week, and we cover 5 of them below. One went to a device firm, and 4 went to finished pharmaceuticals sites, all located outside the US. Medical Devices Curasan AG (Frankfurt Germany) site received a warning letter on August 23, 2017, based on the outcome of an inspection ending May 11, 2017. The [...]

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 [...]

21 02, 2018

Generic Drug Application Submission and Assessment

By | 2018-02-21T16:21:20+00:00 February 21st, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Enforcement News|

The FDA published two related guidance for generic drugs in January:  the 11-page MAPP 5241.3 titled 'Good Abbreviated New Drug Application Assessment Practices' and a 30-page heavily footnoted draft guidance titled ‘Good ANDA Submission Practices.’  Both contribute to the ‘Drug Competition Action Plan’ that is developed to increase drug competition with the production and approval of high-quality generic drugs. [...]

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 [...]

16 02, 2018

Week of Feb 4th 2018 | FDA Sent These Warning Letters for Pharma Companies

By | 2018-02-19T09:41:49+00:00 February 16th, 2018|Biopharma / Pharma, CGMP, FDA Warning Letters, FDAzilla|

The FDA published only seven warning letters this week. Of interest to us are two issued to finished drug manufacturers. The FDA continues their focus on OTC facilities that seemed to begin in 2017. Polaroisin International Co., Ltd. (Taiwan) received a warning letter on January 25, 2018, based on the outcome of an inspection ending September 15, 2017. FDA placed [...]

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 [...]

7 02, 2018

20,000 FDA Warning Letters

By | 2018-02-08T14:16:28+00:00 February 7th, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDA-Regulated Industry, FDAzilla, Food, Medical Devices|

Here at FDAzilla, we’re excited to report that we have just collected our 20,000th FDA Warning Letter, going back to 2000, all completely searchable in our database.  As you may know, the FDA automatically archives warning letters older than 5 years (and just did so with their 2012 collection last month).  Yes it’s true:  arguably, the older the warning letter, the [...]

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, [...]