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•United States

Clinical Formula LLC, Newport Beach, CA – FDA Inspections

Inspection records and compliance data for Clinical Formula LLC in Newport Beach, California. 5 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected December 03, 2021.

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Company Profile

This profile covers Clinical Formula LLC based in Newport Beach, California, United States.

FDA Inspection History

FDA inspections
5
OAI
0
VAI
1
NAI
3
Unclassified
1
Form 483s
1
Warning letters
1

First inspected June 16, 2009. Last inspected December 3, 2021.

Most cited issue areas

  • Scientifically sound laboratory controls2 inspections
  • Control procedures to monitor and validate performance1 inspection
  • Equipment construction - reactive surfaces1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
December 3, 2021VAIHuman Drugs · Drug Quality Assurance1158025
July 11, 2017Not classifiedHuman Drugs · Drug Quality Assurance1019786
February 20, 2013NAIHuman Drugs · Drug Quality Assurance819964
December 8, 2010NAIHuman Drugs · Drug Quality Assurance700630
June 16, 2009NAIFoods & Cosmetics, Human Drugs · Drug Quality Assurance589622
FDA documents

Form 483s (1)

  • Form 483s · December 3, 2021

Warning Letters (1)

  • Warning Letters · April 19, 2022
People (3)
Gavin T. Cua
Person
Bryan A. Galvez
Person
Carolyn E. Becker
Person
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Cosmetic Essence, LLC.
Episciences Inc
Sanitor Corporation
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Company Information

Name

Clinical Formula LLC

FEI Number

2023611

Address

888 W 16th St, Newport Beach, California 92663, United States

Country

United States

ID: 8a18d62e-efa3-4bb2-847e-b4fe3a8bdea5

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Contact
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