After more than a decade of policy development, the FDA’s focus has shifted to auditing and enforcement. Manufacturers are now under the microscope, and outdated or inconsistent SOPs won’t cut it. Recent Form 483 observation letters confirm that the FDA is actively scrutinizing DSCSA compliance—particularly around serialization systems and documentation.
Two Labs has been leading the way in DSCSA strategy and serialization compliance for years. Let’s talk about getting your SOPs, and your team, audit-ready.
