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 [...]

15 02, 2018

3 Steps to Set Up Your Foreign Supplier Verification Program in the Next 30 Days

By | 2018-02-16T22:36:56+00:00 February 15th, 2018|Food, FSMA|

With a couple of words, the FDA drastically altered the expectations of food processors. Those words were: “shifts accountability.” The impact of the FSMA for major companies largely comes down to this transfer as food processors are now responsible for every supplier along the line of bringing products from the farm to the table. One major aspect is the [...]

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 [...]

8 02, 2018

FSMA in a Nutshell

By | 2018-02-16T17:09:28+00:00 February 8th, 2018|Food, FOOD - Featured, FSMA|

FSMA has sent food suppliers into a frenzy, but what does it really entail? While there is much information on the topic, a simplified, initial outline is close to nonexistent.  We decided to fix this problem by providing this resource for those attempting to wrap their minds around what this new act really means. […]

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 [...]

25 01, 2017

FSMA is Here. How Do You Manage 1,000 Food Suppliers?

By | 2018-02-13T10:54:31+00:00 January 25th, 2017|FDA, FDAzilla, Food, FOOD - Featured, quality assurance, Supplier Management|

FSMA is Here. How Do You Manage 1,000 Food Suppliers? The advent of the FSMA in the US means that everyone in your supplier network can expect an inspector to knock at some point, underlining the imperative for supplier accountability to compliance teams. Brand revenue and reputation ride on the outcome. […]

30 06, 2016

5 FEATURES TO LOOK FOR IN A WARNING LETTER

By | 2018-01-26T23:25:53+00:00 June 30th, 2016|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Inspections, FDAzilla, Food, Form FDA 483, Medical Devices, quality assurance|

5 FEATURES TO LOOK FOR IN A WARNING LETTER Warning letters are the FDA’s second level of enforcement actions after issuance of a form 483. The FDA determined that either the firm’s response to the form 483 was inadequate or the observations were serious enough to support issuance of a warning letter.   Often it is possible to determine the corrective actions [...]

16 06, 2016

5 FEATURES TO LOOK FOR IN AN FDA FORM-483

By | 2018-01-26T23:21:30+00:00 June 16th, 2016|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Inspections, FDAzilla, Food, Form FDA 483, Medical Devices, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief A form-483 is the document that the FDA issues at the close of an inspection where they identify observations made during the inspection.  If no observations are made, no 483 is issued.  Based on the response submitted by the firm, the FDA classifies the inspection as:  No Action Indicated [...]