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FDA Inspection
•Abbvie Biotechnology Ltd.•June 10, 2026

Abbvie Biotechnology Ltd. – FDA Inspection, Jun 10, 2026

Record Details

This FDA Inspection record concerns Abbvie Biotechnology Ltd., with an inspection on June 10, 2026, issued by the San Juan District Office, covering human drugs.

Company
Abbvie Biotechnology Ltd.
Inspection Date
June 10, 2026
Product Type
Human Drugs
Office
San Juan District Office
People
  • Christian F. Gomez Lugo
  • Mabany Lizardi (Issuing Officer)
  • Marian E. Ramirez (Company Rep)
View Company Profile

ID · 5171fca6-80bf-44ca-b188-290a1bc76d8e

Inspection Facts

Inspection number
1321476
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 211.100(b)SOPs not followed / documented
  2. 21 CFR 211.113(b)Procedures for sterile drug products
  3. 21 CFR 211.194(a)Complete test data included in records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Abbvie Biotechnology Ltd.

10
DateClassificationOfficeProject area
October 30, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 25, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 1, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 28, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 13, 2017Not classifiedSan Juan District Office
View all 10 other inspections on the company page
Other documents for Abbvie Biotechnology Ltd.
  • FDA Inspection 1222107 - 2023-10-30
  • FDA Inspection 1084057 - 2019-03-25
  • FDA Inspection 1055102 - 2018-06-01
  • FDA Inspection 1012249 - 2017-04-28
  • FDA Inspection 1001477 - 2017-01-13

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