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483
•Aphena Pharma Solutions - Tennessee LLC•December 12, 2013

Aphena Pharma Solutions - Tennessee LLC – FDA 483, Dec 12, 2013

Record Details

Aphena Pharma Solutions-Tennessee, LLC, a drug repackager in Cookeville, TN, received a Form 483 with three observations. The inspection revealed deficiencies in the firm's investigation procedures, specifically regarding the scope of nonconformance investigations and the evaluation of reserve samples. Additionally, the firm's reserve drug product samples were found not to be representative of each lot, and visual examinations for deterioration were not conducted or recorded according to their own procedures.

Company
Aphena Pharma Solutions - Tennessee LLC
Inspection date
December 12, 2013
Product type
drugs
Office
New Orleans District Office
Person
  • Brandon C. Heitmeier
View Company Profile

ID · ff15f097-1a65-4476-9dd2-642e2b854949

Other documents for Aphena Pharma Solutions - Tennessee LLC
  • EIR - 2022-07-22July 22, 2022
  • 483 - 2017-11-16November 16, 2017
  • EIR - 2017-11-16November 16, 2017
  • EIR - 2013-12-12December 12, 2013

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