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•United States

New Vitalis Pharmacy LLC, Louisville, KY – FDA Inspections

Inspection records and compliance data for New Vitalis Pharmacy LLC in Louisville, Kentucky. 3 FDA inspections on record (2 OAI), 2 Form 483s, last inspected July 05, 2023.

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Company Profile

This profile covers New Vitalis Pharmacy LLC based in Louisville, Kentucky, United States.

FDA Inspection History

FDA inspections
3
OAI
2
VAI
1
NAI
0
Form 483s
2
Warning letters
0

First inspected September 7, 2018. Last inspected July 5, 2023.

Most cited issue areas

  • Facility design, influx of lesser quality air1 inspection
  • Failure/inadequate, filter integrity testing1 inspection
  • First pass air blockage, open unit with sterile product1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
July 5, 2023OAIHuman Drugs · Drug Quality Assurance1211023
August 27, 2021OAIHuman Drugs · Drug Quality Assurance1149996
September 7, 2018VAIHuman Drugs · Drug Quality Assurance1065457
FDA documents

Form 483s (2)

  • Form 483s · August 27, 2021
  • Form 483s · September 7, 2018
People (3)
Bei Y. He
Person
Lauren N. Howard
Person
Carl A. Huffman
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Puremedy Inc.
Ehsan Sadri MD
University Rx Specialist, dba University Compounding Pharmacy
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Charles River Laboratories, LLC
Daniel Fred Goodman, M.D.
Lee & Company
Vemulkonda Koneti Rao, M.D.
OurPharma LLC
First Time US Generics LLC
Company Information

Name

New Vitalis Pharmacy LLC

FEI Number

3014391500

Address

4139 Cadillac Ct Ste 201, Louisville, Kentucky 40213, United States

Country

United States

ID: abe57774-8b86-49b9-9135-b8509fc41ecf

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