7-Year Review of GCP Inspections Finds Fewer 483s
An FDA review of 2,386 Good Clinical Practice (GCP) inspections conducted between 2017 and 2023 shows a marked decline in regulatory violations at clinical trial sites. The proportion of inspections resulting in Form 483 observations dropped from 23.5% in 2017 to 10.4% in 2023, with just 0.3% escalating to official action. Most inspections concluded with […]
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7-Year FDA Inspection Review Finds Better GCP Compliance
A retrospective FDA study of 2,386 Good Clinical Practice (GCP) inspections (2017–2023) found a sharp decline in regulatory violations at clinical trial sites. Possible drivers of improvement include: Uncertainties remain: Bottom line: Nearly all inspections (99.7%) required no official action, suggesting improved GCP practices, though questions remain about inspection intensity and workforce changes.
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FDA OPQ FY2024 State of Pharmaceutical Quality: Executive Highlights
Inspection & Compliance Trends Key Takeaway: Foreign oversight is surging—particularly India and China—while global compliance remains strong but uneven. Product Portfolio Growth Key Takeaway: Expansion, especially in biosimilars, is increasing regulatory and quality management demands. Postmarket Quality Signals Key Takeaway: Biologics deviations rising; continued vigilance needed for high-risk product lines. Enforcement & Import Alerts Key […]
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Warning Letter Increasing in 2025: Are You Next?
An FDA warning letter is a public declaration that a company’s quality system has failed to meet critical standards. But beyond the reputational sting, FDA warning letters offer valuable intelligence. Each one reveals patterns, systemic weaknesses, and evolving enforcement priorities that medical device manufacturers can analyze to strengthen compliance and build resilience. This article explores […]
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FDA Flags Hundreds of Adverse Events Connected to Compounded GLP-1 Drugs
Hundreds of people using compounded versions of popular GLP-1 medications — unapproved copies of brand-name weight-loss drugs like Wegovy, Ozempic, Mounjaro, and Zepbound — have reported side effects, some requiring hospitalization, FDA announced. As of July 31, 2025, the agency had received 605 adverse event reports for compounded semaglutide and 545 reports for compounded tirzepatide, […]
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Thyroid Drugs Have Turned Into a MAHA Hot Topic
A recent FDA warning to manufacturers of an old-line thyroid drug has ignited fierce pushback from pharmacists and wellness figures tied to the Make America Healthy Again movement led by Health Secretary Robert F. Kennedy Jr. The big issue is desiccated thyroid extracts — made from dried pig thyroid glands — which have been used […]
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FDA Announces Plan To Shorten Drug Review Time In Voucher Program
FDA announced today that it is starting a program where the FDA commissioner can provide vouchers to drug companies to shorten the review time for a New Drug Application to as little as one or two months, cutting up to a year off the regular review period. The commissioner’s National Priority Voucher or CNPV program […]
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FDA Sends Warning Letter To Sprout Pharma For Social Media Post
Last week, FDA sent a warning letter to Sprout Pharmaceuticals, Inc. for a social media post that promoted ADDYI or flibanserin. The Instagram post discussed Addy’s benefits but did not mention important safety information and related details for the target population. The agency said the CEO Cindy Eckert, shared a People magazine screenshot where a […]
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Sun Pharmaceutical Industries Receives 8-Item 483
Sun Pharmaceutical Industries Limited received an eight-item 483 after a June 2 to 13, 2025 cGMP inspection. The inspection was conducted at the firm’s Halol facility in Gujarat, India. The Halol facility is one of Sun Pharma’s largest facilities and has had regulatory issues before. The last inspection was in May 2022 and it is […]
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FDA Intends to Increase Unannounced Audits of Foreign Manufacturing Facilities
FDA announced last month that it will increase the number of unannounced cGMP inspections at foreign manufacturing plans that produce essential medicines and other medical products intended for the US market. The announcement came a few days after President Trump issued an executive order telling the FDA to give regulatory relief to increase domestic production […]
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