by tmourit | Apr 18, 2026 | Audits, Quality
In regulated industries, backlogs are rarely just an administrative inconvenience. They are often an early warning sign that a quality system is under strain. As companies scale manufacturing, expand testing, launch new products, or work through periods of... by tmourit | Apr 3, 2026 | Audits, Quality, Regulatory
In regulated industries, particularly pharmaceuticals, biologics, medical devices, and 503B outsourcing facilities, a gap assessment is not a formality. It is a strategic diagnostic tool. When done correctly, it reveals whether your Quality Management System (QMS)... by tmourit | Mar 27, 2026 | Audits, Quality, Regulatory
Why Are 503B Pharmacies Receiving FDA Warning Letters? 503B outsourcing facilities are registered under Section 503B of the FD&C Act and are required to comply with current Good Manufacturing Practice (CGMP) regulations under 21 CFR Parts 210 and 211. Warning... by tmourit | Mar 20, 2026 | Audits, Quality
Over the past several years, inspection outcomes for 503B outsourcing facilities have trended in the wrong direction. The U.S. Food and Drug Administration has issued a steady stream of Form 483 observations and Warning Letters citing serious deficiencies in sterile... by tmourit | Mar 6, 2026 | Audits, Quality
On January 16, 2026, the U.S. Food and Drug Administration issued a Warning Letter to Boothwyn Pharmacy, LLC following a 2025 inspection of its sterile compounding operations. For organizations involved in sterile drug production — particularly compounding pharmacies,... by tmourit | Feb 27, 2026 | Audits, Quality
Corrective and Preventive Action (CAPA) is one of the most frequently cited areas in FDA inspections, ISO audits, and notified body reviews. Despite this, many organizations still struggle to implement CAPA systems that are both effective in practice and defensible to...