2 03, 2018

Week of Feb 18th 2018 | FDA Sent These Warning Letters to Device & Pharma Companies

By | 2018-03-06T12:40:26+00:00 March 2nd, 2018|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDAzilla, Medical Devices|

A collection of warning letters were issued from the Center for Tobacco Products this week. In FY2017, the center issued 97% of all warning letters issued by the FDA. Also, the FDA issued one warning letter to a finished drug manufacturer and one to a device manufacturer. Both warning letters were issued to sites outside the US. We cover [...]

27 02, 2018

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

By | 2018-02-27T12:14:29+00:00 February 27th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Warning Letters, FDAzilla, Form FDA 483, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers The FDA issued a collection of guidance the week of February 18th regarding devices, safety, clinical ICH Quality, and administrative items. WHO and TGA each published two new guidance. It was a busy week on the publication front. To see the complete list of laws, regulations, guidance, and concept papers published this week, [...]

26 02, 2018

FSMA Inspection Checklist – What to Do 30 days, 30 hours, and 30 minutes Before Your Inspection

By | 2018-03-06T12:09:34+00:00 February 26th, 2018|CGMP, FDA Inspections, FDA-Regulated Industry, Food, FSMA|

All of the articles and tips flying around the food industry regarding FSMA almost sound like a ticking clock -- reminding us that inspections are just around the corner. Practical steps for compliance are a necessity and most can be prioritized according to a certain time frame. In this article, we will discuss what should be accomplished 30 days, [...]

23 02, 2018

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

By | 2018-02-26T10:16:20+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 [...]

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 [...]