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NEWS & BLOGS
Blog: Blog2
FDA’s Purolea Warning Letter: What AI-Assisted GMP Documentation Means for Manufacturers
Artificial intelligence is rapidly moving into regulated manufacturing environments. Manufacturers are increasingly using AI to assist with regulatory research, SOP drafting, specifications, quality documentation, and other activities that traditionally required significant human effort. But where does the responsibility remain when AI is involved? A recent FDA Warning Letter to Purolea Cosmetics Lab provides a useful enforcement example. The Warning Letter, issued on April 2
Provision Consulting Group
6 days ago5 min read
FDA Form 483 Response Is Not the Finish Line: What the Bausch & Lomb Warning Letter Reveals About CAPA
A response to an FDA Form 483 is an important regulatory step. But it is not necessarily the end of the process. A recent FDA Warning Letter issued to Bausch & Lomb Inc. provides a useful example of how the agency evaluates corrective and preventive actions (CAPA)—particularly when the underlying problems involve sterile manufacturing, contamination control, facility design, and the quality system. The warning letter followed an FDA inspection of Bausch & Lomb's Tampa, Florid
Provision Consulting Group
Sep 194 min read
FDA Sunscreen Regulatory Update: PABA and Trolamine Salicylate Removed from OTC Monograph M020
The U.S. Food and Drug Administration (FDA) is beginning to make meaningful changes to the regulatory framework governing OTC sunscreen products. In 2026, the FDA took two significant actions involving OTC sunscreen active ingredients. In June, the agency added bemotrizinol (BEMT) to OTC Monograph M020—the first new sunscreen active ingredient added to the U.S. OTC sunscreen monograph in 20 years. In September, the FDA finalized an order removing PABA (aminobenzoic acid) and
Provision Consulting Group
Sep 164 min read
What Does It Mean When Torriden Delegates U.S. Regulatory Compliance to Provision Consulting Group?
K-Beauty has entered a different stage in the United States. The question is no longer simply whether Korean beauty brands can attract American consumers. Increasingly, the question is whether brands can build the regulatory, operational, and commercial infrastructure necessary to sustain that growth. That is why we are pleased to announce that Torriden has onboarded Provision Consulting Group to support its U.S. regulatory compliance. Who Is Torriden? Torriden is a Korean sk
Provision Consulting Group
Sep 92 min read
Introducing the Provision Client Portal (Beta): A New Way to Work With Us
At Provision Consulting Group, we know that regulatory consulting projects move fast — and staying on top of project status, deliverables, and communications shouldn't require an inbox full of email threads. That's why we're excited to announce the beta launch of the Provision Client Portal, a dedicated hub built exclusively for our clients. Why We Built This Our goal was simple: reduce repetitive back-and-forth communication and give clients instant access to the documents a
Provision Consulting Group
Sep 92 min read
Why Provision Built R.I.S.E. Turning 50,000+ Real Regulatory Cases into Regulatory Intelligence
AI can search regulations.R.I.S.E. is built to understand how regulation actually works in the U.S. market. That distinction is at the heart of R.I.S.E. — Regulatory Intelligence Strategic Engine, Provision Consulting Group’s proprietary next-generation regulatory intelligence platform. Provision recently completed the development and implementation of R.I.S.E. to address a question that became increasingly important as our regulatory practice grew: How can we turn years of r
Provision Consulting Group
Aug 284 min read
FY2027 FDA Medical Device User Fees Finalized: MDUFA V’s Final Year and What You Need to Know
Companies preparing to enter the US medical device market should take note of a recent FDA announcement. FDA has finalized the FY2027 medical device user fees in the Federal Register. The new rates run from October 1, 2026 through September 30, 2027. On the surface, this looks like a routine annual notice. It isn't quite that simple. The current fee framework, MDUFA V (2023-2027), closes out with this fiscal year. FDA user fees don't stay fixed indefinitely — Congress renegot
Provision Consulting Group
Aug 242 min read
Provision Consulting Group Speaks at ACI Conference on K-Beauty and U.S. Regulatory Challenges
Provision Consulting Group was honored to participate in the American Conference Institute (ACI) Conference on Legal, Regulatory, and Compliance Issues in the Cosmetics and Personal Care Industry, where our Co-CEO, Mr. Sung Kwon, was invited to speak alongside leading attorneys, regulatory professionals, corporate counsel, and industry experts. The ACI conference is widely recognized as an important forum for professionals working across the legal, regulatory, compliance, cos
Provision Consulting Group
Aug 184 min read
MDUFA VI: Why FDA Device Reviews Are Getting Tougher, Not Faster
There's a quiet hope that keeps circulating among medical device companies eyeing the US market. "Maybe the next round of reforms will finally speed things up." Application volume keeps climbing while the reviewer headcount stays flat, so the thinking goes that the next policy overhaul has to bring some relief. The signal FDA just sent points the other way. Not faster. Tighter. MDUFA Isn't Just a Fee Schedule — It's a Five-Year Deal Between FDA and Industry Getting a device o
Provision Consulting Group
Aug 143 min read
Trapped in Customs: The Hidden Triggers Behind FDA Import Alerts for Medical Devices
This is the second post in a series covering recurring FDA Import Alert patterns by industry. Part 1 covered food and dietary supplements; this one covers medical devices. Read More:: Container Stuck at a U.S. Port — What Triggers an FDA Import Alert for Food and Supplements Even companies with a 510(k) clearance sometimes find their shipments held at customs — and this question keeps coming up in medical device inquiries. Clearance and the ability to actually clear customs a
Provision Consulting Group
Aug 34 min read
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