RAPS

Data integrity is ‘biggest issue’ for drug, API firms during inspections, FDA official says

Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during ...
RAPS

FDA finds data integrity problems in recent warning letters

The US Food and Drug Administration (FDA) has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices (GMPs) related to the ...
Reuters

U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plant

May 29 (Reuters) - The U.S. Food and Drug Administration has flagged data integrity, manufacturing and maintenance lapses at one of Dabur India's (DABU.NS), opens new tab plants following an ...
PharmTech

What FDA's AI Warning Letter Tells Us About GMP Accountability

FDA tied AI-assisted drafting directly to established Quality Unit accountability under 21 CFR 211.22(c) for approving/rejecting specifications and procedures affecting identity, strength, quality, ...

Dabur India says US FDA issues import alert for Silvassa plant drugs

Dabur India said the United States Food and Drug Administration (USFDA) issued Import Alert 66-40 for drugs made at part of its Silvassa facility after an inspection flagged data integrity and ...
moneycontrol.com

Intas gets USFDA warning over data integrity, quality lapses at Dehradun plant

Intas Pharma's Dehradun facility receives USFDA warning letter. USFDA cites lapses in quality systems and data integrity. New US approvals halted until compliance issues are resolved. Intas ...
JD Supra

FDA Releases Final Guidance on Best Practices for Bioresearch Monitoring Inspections

On December 18, 2025, the Food and Drug Administration (FDA) released a final guidance entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The guidance was issued to ...
JD Supra

FDA one-day inspections pilot: What to expect and how to prepare

The U.S. Food and Drug Administration (FDA) recently announced the launch of a pilot program involving abbreviated, one-day inspectional assessments at manufacturing and other lower-risk facilities.
CNBCTV18

Glenmark Pharmaceuticals receives six observations after US FDA inspection of Goa plant

Glenmark Pharmaceuticals has received a Form 483 with six observations following a US FDA GMP inspection of its Goa ...
Medical Dialogues

Glenmark Receives 6 USFDA Observations for Goa Manufacturing Plant

Glenmark Pharmaceuticals Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practice (GMP) ...
CNBCTV18

Dabur India flags US FDA import alert on certain drug products from Silvassa plant

The US FDA has issued Import Alert 66-40 for drugs manufactured at a part of Dabur India’s Silvassa facility after identifying deficiencies related to data integrity and maintenance during an ...