Triclinic Labs Completes Successful Two-Day Food and Drug Administration Audit
There were no FDA findings and the inspection was classified as “No Action Indicated “, or NAI.
We are pleased the FDA was able to complete their inspection of our facilities, SOPs, and systems and depart with no findings and no 483s.”
LAFAYETTE, IN, UNITED STATES, February 8, 2024 /EINPresswire.com/ -- Triclinic Labs, Inc., a Food and Drug Administration (FDA) registered contract pharmaceutical physical, organic, and analytical chemistry laboratory which follows Good Manufacturing Practices (cGMP) completed an unannounced inspection by the agency over two days from January 16 through January 17th, 2024. This was a GMP surveillance establishment inspection of our facilities conducted in accordance with compliance program CP 7356.002 Drug Manufacturing Inspections. There were no FDA findings and the inspection was classified as “No Action Indicated “, or NAI. No refusals were encountered, and no samples were collected. Ms. Brandi Albea, Triclinic Labs’ Director of Quality Systems led the inspection. “We are pleased the FDA was able to complete their inspection of our facilities, SOPs, and systems and depart with no findings and no 483s” she said. “It speaks to the tremendous effort and investment Triclinic has made in subject matter experts and systems to support our clients in their cGMP testing and release efforts,” she added. — Brandi Albea
Triclinic Labs offers leading analytical testing, method development, validation, and release testing of pharmaceuticals, medical devices, and other specialty chemicals. They are specialists in solid-state materials characterization.
Please see https://tricliniclabs.com for more information or call 765-588-5624.
Shawn Comella
Triclinic Labs, Inc.
+1 7655886200
email us here
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