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FDA Inspection
•Brooks Life Sciences Inc•July 6, 2018

Brooks Life Sciences Inc – FDA Inspection, Jul 6, 2018

Record Details

This FDA Inspection record concerns Brooks Life Sciences Inc, with an inspection on July 6, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Brooks Life Sciences Inc
Inspection Date
July 6, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Lewis K. Antwi (Issuing Officer)
View Company Profile

ID · 2db46a22-8a45-4fa9-b542-a0ff9a2c6da9

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1058044
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 1271.200(a)Cleaned, sanitized per established schedules

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Brooks Life Sciences Inc

6
DateClassificationOfficeProject area
August 12, 2025NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
August 22, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 5, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
June 5, 2014NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
July 25, 2012NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 6 other inspections on the company page
Other documents for Brooks Life Sciences Inc
  • FDA Inspection 1281588 - 2025-08-12
  • FDA Inspection 1103075 - 2019-08-22
  • FDA Inspection 983379 - 2016-08-05
  • FDA Inspection 881805 - 2014-06-05
  • FDA Inspection 791875 - 2012-07-25

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