Company
United StatesZiptek LLC, Sarasota, FL – FDA Inspections
Inspection records and compliance data for Ziptek LLC in Sarasota, Florida. 2 FDA inspections on record, 1 Form 483, last inspected May 22, 2024.
Company Profile
This profile covers Ziptek LLC based in Sarasota, Florida, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected May 8, 2018. Last inspected May 22, 2024.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
- Documentation of validated process performance1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 22, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1239943 |
| May 8, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1051750 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Ziptek LLC
FEI Number
3013722959
Address
1250 S Tamiami Trl Ste 303, Sarasota, Florida 34239, United States
Country
United States
ID: ce6d62bc-fc2e-43c5-afc4-79a3c40d5b4c