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News / Insights
News & Blog
Regulatory updates. Practical perspectives.
A clearer view of what comes next.
Blog: Blog2
Provision CEO Sung Kwon to Speak at Cosmoprof Asia Hong Kong 2026
Provision Consulting Group is pleased to announce that Sung Kwon, CEO of Provision Consulting Group, will be participating as a speaker at Cosmoprof Asia Hong Kong 2026. Sung Kwon will join the session “K-Beauty 3.0: Asia’s Innovation Powerhouses Captivating Gen Z,” taking place on November 12 at the Hong Kong Convention & Exhibition Centre. Event Details Session: K-Beauty 3.0: Asia’s Innovation Powerhouses Captivating Gen Z Date: November 12, 2026 Time: 3:00–3:45 PM HKT (UTC
Provision Consulting Group
Oct 21 min read
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
Sep 235 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
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