Quality & compliance

Quality and compliance you can trace.

Aidarex operates in a highly regulated environment. Our quality and compliance programs are designed to meet FDA, DEA, DSCSA, cGMP, state, and federal requirements.

Key compliance areas

Built into every step of our operation.

  • FDA establishment registration and drug listing
  • cGMP-aligned repackaging operations
  • DSCSA serialization and traceability
  • DEA compliance for controlled substances
  • State wholesale distributor and pharmacy licenses
  • VAWD certified by the NABP
  • Supplier qualification and incoming material review
  • Lot-level traceability and expiry control
  • Recall and market-withdrawal procedures
  • DoD and federal audit readiness
Aidarex repackaging facility

Recall transparency

Open about recalls.

Aidarex participates in FDA-published recalls when required. For current recall information, visit the FDA recalls database or contact Aidarex directly.

Questions about our quality systems or licensing?

Contact us