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483
•ImprimisRx NJ•August 5, 2022

ImprimisRx NJ – FDA 483, Aug 5, 2022

Record Details

ImprimisRx NJ, a producer of sterile and non-sterile drug products, was cited for significant deficiencies in aseptic processing, environmental control, and cleaning practices during an FDA inspection. Observations included visibly dirty ISO 5 areas, inadequate personnel gowning and material disinfection, poor cleanroom maintenance, and issues with air quality and unidirectional airflow. The firm also released drug products with inconsistent potency due to variable capsule filling.

Company
ImprimisRx NJ
Inspection date
August 5, 2022
Product type
drugs
Office
New Jersey District Office
People
  • Amy N. Chen (Investigator)
  • Tekalign Wondimu ( Drug Investigator)
  • Sena G. Dissmeyer
View Company Profile

ID · e4cc7967-3ab1-43d0-913d-52bbaafb5198

Violation Codes3
21 U.S.C. 324(a)(4)21 CFR 331(c)FD&C Act 905(j)

Full citation text and observation details available on the Dashboard.

Other documents for ImprimisRx NJ
  • WARNING_LETTER - 2022-08-05August 5, 2022
  • 483 - 2019-04-09April 9, 2019
  • UNTITLED_LETTER - 2018-09-25September 25, 2018
  • 483 - 2017-07-10July 10, 2017
  • 483 - 2015-09-30September 30, 2015

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