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 [...]

20 11, 2017

Deep Pockets | Does the FDA Get Tougher if the Owner Gets Richer?

By | 2018-02-14T12:13:07+00:00 November 20th, 2017|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement Trends, FDA-Regulated Industry, FDAzilla, Form FDA 483, MOST POPULAR, Pharma - Featured|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in many functional areas.  Let’s talk about activities in the GMP area.  Firms may not be able to fully rely on past inspections by the FDA to predict the extent of remediation that might be necessary [...]

18 08, 2016

A Bad 483 Could Cost A Company Millions

By | 2018-02-14T12:06:45+00:00 August 18th, 2016|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Inspections, Form FDA 483, MOST POPULAR|

“Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.” I heard this from a reputable Head of Manufacturing of one of the largest biopharma companies in the world.  While most pharma and med device companies seems to learn quickly from everyone else’s mistakes, companies still occasionally get a “moderately bad” 483.  And then [...]

30 04, 2016

Does an FDA Import Alert automatically equate to an impending FDA Warning Letter?

By | 2018-02-14T12:10:07+00:00 April 30th, 2016|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices, MOST POPULAR|

by Barbara Unger, FDAzilla GMP Quality Expert INDIA | IMPORT ALERT 66-40 and Association with Warning Letters Regarding These Sites | Detention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs  […]