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483
•Belcher Pharmaceuticals, LLC•November 4, 2022

Belcher Pharmaceuticals, LLC – FDA 483, Nov 4, 2022

Record Details

Belcher Pharmaceuticals, LLC in Largo, FL, was inspected by the FDA, resulting in two observations related to inadequate laboratory controls and insufficient investigation records. The firm failed to prevent potential contamination of drug product ingredients and did not adequately investigate out-of-specification results, raising concerns about product quality and data reliability.

Company
Belcher Pharmaceuticals, LLC
Inspection date
November 4, 2022
Product type
drugs
Office
Office of Medical Device and Radiological Health Division II
People
  • Brittny C. Cargo (Medical Officer at FDA)
  • Harshal J. Desai (issuing_officer)
  • Saundrea A. Munroe (Drug Specialist / Drug Investigator)
View Company Profile

ID · 863c5017-bb5f-423b-a090-ea14f1b0e8f0

Other documents for Belcher Pharmaceuticals, LLC
  • 483 - 2024-08-16August 16, 2024
  • 483 - 2021-11-15November 15, 2021
  • EIR - 2019-05-24May 24, 2019
  • EIR - 2016-05-13May 13, 2016
  • CRL

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