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483
•United Exchange Corporation•December 4, 2019

United Exchange Corporation – FDA 483, Dec 4, 2019

Record Details

An FDA inspection of United Exchange Corporation, a distributor in Cypress, CA, revealed significant deficiencies across its operations. The firm lacks adequate written procedures for its quality control unit, fails to properly investigate product complaints, and has not established reliable supplier qualifications or sufficient finished product specifications and sampling plans. These issues indicate a systemic failure in ensuring the quality and purity of drug products.

Company
United Exchange Corporation
Inspection date
December 4, 2019
Product type
drugs
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Bryan A. Galvez (Pharmaceutical investigator)
View Company Profile

ID · d5c23582-7d61-4520-9bc2-3f6fb80c1532

Other documents for United Exchange Corporation
  • 483 - 2019-12-19December 19, 2019
  • WARNING_LETTER - 2018-04-06April 6, 2018
  • EIR - 2018-02-14February 14, 2018
  • 483 - 2018-02-14February 14, 2018

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