Druggmpreport

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June 2018

No. 311

Headlines

Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

Time Between Plant Inspections and Classification Letters Continuing to Shrink, Says FDA Official

The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, one of the agency’s top inspection officials said Friday. Read More

EMA Conducting Fewer GMP But More GCP and Pharmacovigilance Inspections

The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the amount of pharmacovigilance inspections than the previous year. Read More

FDA Clarifies Term ‘Outsourcing Facility,’ Requirements for 503A Compounders

As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility. Read More

MHRA Cites Data Management, Integrity Issues in GCP Inspections

Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Read More

Cerno Pharma Hit With Warning Letter Over Adulterated Products

The FDA slammed Cerno Pharmaceuticals for producing adulterated drugs at its Miami, Florida facility. Read More

Reine Lifescience Cited for Adulterated APIs

The FDA hit API manufacturer Reine Lifescience with a warning letter for significant GMP violations observed during a November inspection of its facility in Gujurat, India. Read More

Chinese Firm Warned for Data Integrity, Record Maintenance Issues

The FDA issued a warning letter to Jilin Shulan after an inspection of the firm’s Shulan City, Jilin Province facility revealed significant GMP deviations for active pharmaceutical ingredients. Read More

FDA Calls Out Manufacturer for Maintenance, Quality Control

The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality control issues. Read More

SCOTUS Urged to Review Merck Case Over Failure-to-Warn Claims

The Trump administration is urging the Supreme Court to take up a case testing whether the FDA’s refusal to approve a warning label on drugs preempts state laws that may require such labels. Read More

FDA Cites New Zealand Firm for Multiple Violations

The FDA observed multiple deficiencies related to equipment and quality control during a November inspection of Douglas Manufacturing’s finished drug facility in Lincoln, Auckland. Read More

Noven Pharmaceuticals Cited for Quality Deficiencies

The FDA issued a Form 483 to Noven Pharmaceuticals after observing numerous problems at the transdermal drug manufacturer’s Miami, Florida facility. Read More

AbbVie Cited Over Complaint Handling, Product Sampling

The FDA issued a Form 483 to AbbVie for its handling of complaints and samples. Read More

FDA Outlines Supply Chain Security Waiver Process

The FDA outlined its latest thinking on granting exemptions from drug supply chain security requirements in a new draft guidance. Read More