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Inspection Preparation

/Inspection Preparation
Inspection Preparation 2018-02-14T11:42:35+00:00

  • The Ultimate Guide to Researching Your FDA Inspector

The Ultimate Guide to Researching Your FDA Inspector

February 9th, 2018|0 Comments

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|1 Comment

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|0 Comments

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 [...]

1801, 2018

FDA Issued 42 Product Recalls, Import Alerts, and Consent Decrees in December 2017

By | January 18th, 2018|Categories: Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Enforcement News, FDA Inspections, FDAzilla|0 Comments

Here’s our monthly summary of product recalls, import alerts, consent [...]

1310, 2017

FDA Issued 36 Product Recalls, Import Alerts, and Consent Decrees in September 2017

By | October 13th, 2017|Categories: Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Enforcement News, FDA Inspections, FDAzilla, Medical Devices|0 Comments

Here’s our monthly summary of product recalls, import alerts, consent [...]

2509, 2017

The Heightened Importance of Contract Manufacturing Organizations

By | September 25th, 2017|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, quality assurance|0 Comments

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence [...]

2509, 2017

New FDA GMP Inspection Model

By | September 25th, 2017|Categories: Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, Inspection - Features, quality assurance|1 Comment

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence [...]

1409, 2017

FDA Issued 66 Product Recalls, Import Alerts, and Consent Decrees in August 2017

By | September 14th, 2017|Categories: Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Enforcement News, FDA Inspections, Medical Devices|0 Comments

Here’s our monthly summary of product recalls, import alerts, consent [...]

2308, 2017

Summer Enforcement Actions for Compounding Pharmacies and Outsourcing Facilities

By | August 23rd, 2017|Categories: Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, quality assurance|0 Comments

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence [...]