CDMO News

Pace Life Sciences Secures FDA Approval for Central Lab

  • Pace Life Sciences received a positive FDA inspection report for its Oakdale laboratory.
  • The Oakdale facility, alongside the Puerto Rico site, demonstrates robust quality and compliance in CDMO services.

Pace Life Sciences, a full-service FDA-registered GMP analytical testing laboratory and contract development and manufacturing organization (CDMO), has announced a successful inspection from the Food and Drug Administration (FDA) for its Oakdale central laboratory.

“The latest successful inspection of our Oakdale central laboratory further underscores our steadfast quality leadership, the expertise of our laboratory professionals, and our commitment to data integrity and compliance through robust quality systems,” stated Lou Forcellini, head of quality assurance at Pace Life Sciences.

Earlier this year, the company’s laboratory in San German, Puerto Rico, also passed an FDA inspection. This inspection validated the harmonised quality systems across both facilities, reflecting the company’s dedication to maintaining high standards.

The 60,000 square foot Oakdale location has been instrumental in testing gene therapies and other critical drugs. It supports clients from early-stage research through to commercialisation, offering comprehensive testing services for raw materials, active pharmaceutical ingredients (APIs), finished pharmaceuticals, and biologics.

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