Countrywide Import Alert Among Recent FDA Enforcement Activities

At the International GMP Conference held virtually in early March 2021 co-sponsored by the University of

Redica Systems Expert Jerry Chapman to Present at SQA Annual Meeting

Next week, a virtual conference will feature a presentation by Redica Systems Senior GMP Quality Expert

Data Integrity Concerns Discovered in Gene Therapy Product Submissions

Gene therapies are an emerging and promising field of medicine that offers cures for rare and debilitating

FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer

FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a.

OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns

December is generally a slow time when it comes to posting of FDA Warning Letters. Nevertheless, on Dec.

FDA Warning Letters: 11/22/2020 & 12/1/2020

The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter

Part II: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

[Editor's Note: This is Part II of an analysis of the FY2019 UK MHRA GMP deficiencies by Redica Systems

Part I: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

[Editor's Note: Below is Part I of an analysis of the U.K. MHRA GMP deficiencies for 2019. Part II will

FDA FY2020 Drug Inspection Observations and Trends

A comprehensive GMP intelligence program includes monitoring health authority enforcement actions. 

Webinar – How to Build and Implement a QMS for Small Pharma and Biotech Firms

Webinar – Dive Into The New Enforcement Analytics

Webinar – The Ecosystem for Smart Combination Products

Report – Analysis of 2019 UK MHRA GMP Inspection Findings

APAC Trend Report

Report – FDA FY2020 Drug Observations and Trends

Assessment – Investigator Snapshot

Assessment – Peer Benchmark Report

Assessment – CFR Trend Report