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•Q LABS, LLC•November 21, 2019

FDA 483 - Q LABS, LLC - November 21, 2019

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Record Details

Q Laboratories Inc, a control laboratory in Cincinnati, OH, was cited for failing to fully follow its quality control unit procedures. Specifically, the firm did not close out-of-specification (OOS) investigations within the required timeframe and lacked proper justification documentation for extensions, as mandated by its own SOPs. This indicates deficiencies in their quality system and adherence to internal protocols.

Company
Q LABS, LLC
Inspection Date
November 21, 2019
Product Type
Drugs
Office
Cincinnati District Office
Person
  • Jon P. Antoniou
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ID · 67684f99-327b-463c-aec6-0aeb06518093

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