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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

FSMA Has Arrived – Here’s What We Know So Far

By | 2018-02-16T11:04:39+00:00 February 9th, 2018|FDAzilla, FOOD - Featured, MOST POPULAR|

Since the introduction of FSMA in 2011, the FDA issued new guidance to the Food Industry for GMP and HARPC (Hazard Analysis and Risk-Based Preventive Controls). This guidance was encapsulated in 21 CFR 117, which is slated to replace 21 CFR 110. The biggest difference in 21 CFR 110 and 21 CFR 117 is that [...]

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 [...]

5 02, 2018

FDA Sent These 16 Warning Letters for Pharma Companies | January 2018

By | 2018-02-05T16:39:23+00:00 February 5th, 2018|FDAzilla|

We took a snapshot of the 16 warning letters the FDA sent to pharmaceutical companies last month.  The “Violation of the Month” was failing to bear adequate directions for the drug’s intended use. From pharmaceuticals in New Jersey, Japan, and more, here they are (starting with the most recent): […]

1 02, 2018

FDA Sent These 15 Warning Letters for Pharma Companies | December 2017

By | 2018-02-01T16:35:03+00:00 February 1st, 2018|FDAzilla|

We took a snapshot of the 15 warning letters (yes, 15) the FDA sent to pharmaceutical companies in December.  Drug manufacturing violations ranged from failing to establish and follow adequate written procedures to failing to reveal consequences that could result from the use of a drug. From pharmaceuticals in San Diego, Korea, and more, here they are (starting with the [...]

29 01, 2018

Last 30 483s Customers Have Purchased – January 2018

By | 2018-01-29T15:33:18+00:00 January 29th, 2018|FDAzilla, Last 30 483s Purchased|

We see a lot of people, all throughout the world, purchasing 483s from our FDA document store.  For example, this month customers came from Ireland, India, and China.  Here are some of the tools of the trade they purchased from us: […]

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, [...]