FDA Inspection
Transdermal Cap Inc.Transdermal Cap Inc. – FDA Inspection, May 29, 2013
Record Details
This FDA Inspection record concerns Transdermal Cap Inc., with an inspection on May 29, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Transdermal Cap Inc.
- Inspection Date
- May 29, 2013
- Product Type
- Devices
View Company Profile
ID · c7cb8597-9d1e-4233-934d-9afc96aad392
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 832254
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Transdermal Cap Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2025 | NAI | Cincinnati District Office | Postmarket Assurance: Medical Devices |
| March 26, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 22, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 30, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Transdermal Cap Inc.
- FDA Inspection 1271850 - 2025-06-06
- FDA Inspection 1229921 - 2024-03-26
- FDA Inspection 988458 - 2016-09-22
- FDA Inspection 932521 - 2015-06-30
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.