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FDAzilla Blog 2018-02-20T09:29:05+00:00

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Medical Device Blog

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Food Blog

FOOD

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RECENT POSTS

  • New FDA 483s

86 New FDA 483s | June 18th 2018

June 18th, 2018|Biopharma / Pharma, CGMP, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

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 [...]

  • Warning Letters

Week of June 3rd 2018 | FDA Sent These Warning Letters to Pharma Companies

June 15th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

FDA warned 9 firms that operate a total of 53 websites to stop illegally marketing [...]

  • The FDA and MHRA’s Most Recent Drug Inspection Observations

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

June 14th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Warning Letters, Form FDA 483, Medical Devices|

Continued from Part 1 and Part 2... MHRA Inspection Deficiencies I won’t reproduce the graphics from [...]

  • GMP Scan

GMP Regulatory Newsletter: Summary Scan | Week of 6/3/18

June 13th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers: A handful of guidance documents published this week from [...]

INSPECTION PREPARATION

  • The Ultimate Guide to Researching Your FDA Inspector

The Ultimate Guide to Researching Your FDA Inspector

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 [...]

  • New FDA GMP Inspection Model

New FDA GMP Inspection Model

September 25th, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, Inspection - Features, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP [...]

  • 10 Ways to Prepare for a GMP Inspection

10 Ways to Prepare for a GMP Inspection

January 26th, 2017|CGMP, FDA Inspections, FDAzilla, Inspection - Features|

How to Prepare for a GMP Inspection for Small and Virtual Companies by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when [...]

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