FDA Inspection
Cosmed Group, Inc. dba Cosmed of PA.Cosmed Group, Inc. dba Cosmed of PA. – FDA Inspection, Mar 25, 2022
Record Details
This FDA Inspection record concerns Cosmed Group, Inc. dba Cosmed of PA., with an inspection on March 25, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 25, 2022
- Product Type
- Drugs
View Company Profile
ID · 3085eb11-e779-4ea8-8527-306e8ca74b14
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1165323
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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 |
| August 17, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 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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