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FDA Inspection
•McLaren Northern Michigan•August 4, 2026

McLaren Northern Michigan – FDA Inspection, Aug 4, 2026

Record Details

This FDA Inspection record concerns McLaren Northern Michigan, with an inspection on August 4, 2026, issued by the Detroit District Office, covering biologics.

Company
McLaren Northern Michigan
Inspection Date
August 4, 2026
Product Type
Biologics
Office
Detroit District Office
Person
  • Irina Gaberman (FDA Associated Person)
View Company Profile

ID · 73c6abd5-d4a3-425a-844b-7c90a59e4280

Inspection Facts

Inspection number
1329420
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
  2. 21 CFR 606.160(b)Required records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of McLaren Northern Michigan

6
DateClassificationOfficeProject area
June 12, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 24, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 5, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 14, 2012NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 2, 2010NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for McLaren Northern Michigan
  • FDA Inspection 1097340 - 2019-06-12
  • FDA Inspection 1025480 - 2017-08-24
  • FDA Inspection 929603 - 2015-06-05
  • FDA Inspection 811305 - 2012-12-14
  • FDA Inspection 701383 - 2010-12-02

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