FDA Inspection
Cosmed Group, Inc. dba Cosmed of PA.Cosmed Group, Inc. dba Cosmed of PA. – FDA Inspection, Aug 17, 2018
Record Details
This FDA Inspection record concerns Cosmed Group, Inc. dba Cosmed of PA., with an inspection on August 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f903cf80-881a-4b2b-a9a9-5397a1c745a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062318
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cosmed Group, Inc. dba Cosmed of PA.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2026 | NAI | Philadelphia District Office | Postmarket Assurance: Medical Devices |
| March 25, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 24, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 12, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 7, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cosmed Group, Inc. dba Cosmed of PA.
- FDA Inspection 1306776 - 2026-03-11
- FDA Inspection 1165323 - 2022-03-25
- FDA Inspection 923685 - 2015-04-24
- FDA Inspection 848369 - 2013-09-12
- FDA Inspection 712892 - 2011-03-07
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