FDA Green Lights Integra LifeSciences Corporation Puerto Rico Plant

Integra LifeSciences (NSDQ:IART) said the FDA determined its remediation efforts at a Puerto Rico manufacturing plant flagged with a warning letter last February have been effective.

The FDA issued a Form 483 after inspections in the fall of 2012, citing concerns about process validations, corrective and preventative actions, and document controls.

Integra said it hired 3rd-party consultants to assess its procedures and processes to ensure products manufactured at the plant were in accordance with applicable regulations.

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