What Is a Gap Assessment and Why It Matters
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)...
503B FDA Inspections: Common Findings and How to Prepare
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...
Why 503B Pharmacies Are Struggling with FDA Inspections
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...
FDA Warning Letter to Pharmacy: What the Industry Should Learn
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,...
How Do You Implement CAPA That Actually Works (and Satisfies Auditors)?
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...
Can Small or Startup Life Science Companies Be Compliant Without a Full QA Team?
For many early stage life science companies, regulatory compliance feels like a catch-22. Regulators expect robust quality systems, documented processes, and ongoing oversight—yet hiring a full in-house Quality Assurance (QA) team is often unrealistic due to cost,...