FDA Inspection
Transdermal Cap Inc.Transdermal Cap Inc. – FDA Inspection, Jun 30, 2015
Record Details
This FDA Inspection record concerns Transdermal Cap Inc., with an inspection on June 30, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Transdermal Cap Inc.
- Inspection Date
- June 30, 2015
- Product Type
- Devices
View Company Profile
ID · f2579d5c-3e0d-43ab-ac4e-b1f7964191f5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 932521
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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 |
| May 29, 2013 | VAI | Center for Devices and Radiological Health | Compliance: 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 832254 - 2013-05-29
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