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FDA Inspection
•Galephar Pharmaceutical Research Inc.•October 18, 2024

Galephar Pharmaceutical Research Inc. – FDA Inspection, Oct 18, 2024

Record Details

This FDA Inspection record concerns Galephar Pharmaceutical Research Inc., with an inspection on October 18, 2024, issued by the San Juan District Office, covering human drugs.

Company
Galephar Pharmaceutical Research Inc.
Inspection Date
October 18, 2024
Product Type
Human Drugs
Office
San Juan District Office
People
  • Christian F. Gomez Lugo
  • Marian E. Ramirez (Company Rep)
View Company Profile

ID · f30929e1-c1b3-4022-a855-84862f621769

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1252181
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

1
  1. 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Galephar Pharmaceutical Research Inc.

6
DateClassificationOfficeProject area
October 24, 2018Not classifiedSan Juan District Office
November 23, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 29, 2011VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 4, 2010NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 30, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 6 other inspections on the company page
Other documents for Galephar Pharmaceutical Research Inc.
  • FDA Inspection 1069913 - 2018-10-24
  • FDA Inspection 952658 - 2015-11-23
  • FDA Inspection 747557 - 2011-09-29
  • FDA Inspection 667983 - 2010-06-04
  • FDA Inspection 559310 - 2009-01-30

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
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