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483
•Molecular Ms Diagnostics, LLC•April 16, 2024

Molecular Ms Diagnostics, LLC – FDA 483, Apr 16, 2024

Record Details

Molecular Ms Diagnostics, LLC in Warwick, RI, a contract test laboratory, was inspected by the FDA and cited for two observations. The inspection revealed significant issues with data integrity due to inadequate computer system controls and deficiencies in equipment maintenance and requalification for temperature-controlling units. These findings indicate a moderate level of severity concerning quality control and data reliability.

Company
Molecular Ms Diagnostics, LLC
Inspection date
April 16, 2024
Product type
drugs
Office
New England District Office
People
  • Erik W. Koester (Investigator)
  • Mark W. Jackson (Consumer Safety Officer)
View Company Profile

ID · 87604ebf-3413-4859-a720-709184a0670e

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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