Form FDA 483

86 New FDA 483s | June 18th 2018

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

FINAL Part 3: The FDA and MHRA’s Most Recent Drug Inspection Observations

Continued from Part 1 and Part 2... MHRA Inspection Deficiencies I won’t reproduce the graphics from the MHRA slide deck; do read those because they contain a wealth of information at a granular level. Figure 3A shows the distribution of deficiencies among the 3 classifications by actual number for 2015 and 2016. Figure 3B shows this distribution of deficiencies among [...]

Part 2: The FDA and MHRA’s Most Recent Drug Inspection Observations

Continued from Part 1... FDA 483 INSPECTION OBSERVATIONS: It all starts with Table 1... Table 1 shows the fifteen (15) most frequent inspection observation citations (the tabulation on the FDA website shows all). Table 1 presents data in the order of those observations with the highest to lowest number for 2017, modified as described in the ‘Introduction’ section of [...]

88 New FDA 483s | June 5th 2018

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

Part 1: The FDA and MHRA’s Most Recent Drug Inspection Observations

INTRODUCTION A comprehensive GMP Intelligence program includes monitoring of health authority enforcement actions, including: FDA forms-483 Establishment Inspection Reports Warning Letters Recalls Import Alerts Consent Decree Agreements EU Reports of GMDP Noncompliance  This 3-part article series presents recent publications of GMP drug product inspection data from CDER and MHRA: The CDER data are from drug inspections conducted in FY2017 [...]

96 New FDA 483s | May 21st 2018

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

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114 New FDA 483s | May 7th 2018

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

The Secret Life of (b)s

I recently discovered a gap in my education. Like you, I’ve seen my share of redacted 483s and EIRs. Those redactions are marked with a “(b)” followed by a number in parentheses. I’m normally a curious person, but it never occurred to me that those letters and numbers had a meaning. I had an aha (and color me red) moment [...]