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FDA Inspection
•Cosmed Group, Inc. dba Cosmed of PA.•March 11, 2026

Cosmed Group, Inc. dba Cosmed of PA. – FDA Inspection, Mar 11, 2026

Record Details

This FDA Inspection record concerns Cosmed Group, Inc. dba Cosmed of PA., with an inspection on March 11, 2026, issued by the Philadelphia District Office, covering medical devices & rad health.

Company
Cosmed Group, Inc. dba Cosmed of PA.
Inspection Date
March 11, 2026
Product Type
Medical Devices & Rad Health
Office
Philadelphia District Office
Person
  • Matthew D. Schnittker (Issuing Officer)
View Company Profile

ID · 217f8aeb-3756-4920-a1fd-f03d89272a67

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1306776
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

1
  1. ISO 13485:2016 Clause 7.1Product realization risk management processes not documented

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Cosmed Group, Inc. dba Cosmed of PA.

5
DateClassificationOfficeProject area
March 25, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 17, 2018VAICenter for Devices and Radiological HealthCompliance: Devices
April 24, 2015NAICenter for Devices and Radiological HealthCompliance: Devices
September 12, 2013NAICenter for Devices and Radiological HealthCompliance: Devices
March 7, 2011NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Cosmed Group, Inc. dba Cosmed of PA.
  • FDA Inspection 1165323 - 2022-03-25
  • FDA Inspection 1062318 - 2018-08-17
  • FDA Inspection 923685 - 2015-04-24
  • FDA Inspection 848369 - 2013-09-12
  • FDA Inspection 712892 - 2011-03-07

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