FDA Inspections

21 03, 2018

What Can Mid-Sized Food Companies Learn About FSMA from the Big Shots?

By | 2018-03-21T12:52:24+00:00 March 21st, 2018|FDA Inspections, FOOD - Featured, FSMA|

FSMA, signed into law by President Obama in 2011, made sweeping reforms within the food industry. For some, these reforms were necessary to enact sooner than others based on differing compliance dates. Large food companies came first, to be followed by smaller businesses. So how can mid-sized food companies look to those that have already been through the wringer [...]

16 03, 2018

Week of Mar 4th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-03-16T16:03:32+00:00 March 16th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Inspections, FDA Warning Letters, FDAzilla|

FDA posted six new warning letters this week including one to a compounding pharmacy and two to finished drug manufacturers. Both finished drug manufacturers are located outside the US. We address those below. Finished Drug Manufacturers: Zhejiang Ludao Technology Co., Ltd (Taizhou, China) received a warning letter on February 23th 2018 based on the outcome of an inspection ending [...]

13 03, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 3/4/18

By | 2018-03-13T12:14:07+00:00 March 13th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers It was a light week on the guidance front particularly from the EMA and the FDA. On the other hand: WHO published two drafts. Health Canada published a final revision to their drug GMPs. And, perhaps more important than all (I admit I’m prejudiced on the topic), is the final version of the [...]

6 03, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 2/25/18

By | 2018-03-06T12:39:19+00:00 March 6th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Inspections, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers FDA published four guidance documents this week: Two that address implementation of drug track and trace activities Two that focus more on medical and safety The EMA published one item focused on inclusion of excipients in labeling. The non-guidance set of publications includes items from the EMA, FDA, MHRA, CDSCO, and TGA. Also [...]

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, [...]

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 [...]

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 [...]

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 [...]