Company
United StatesBiocoat, Inc., Horsham, PA – FDA Inspections
Inspection records and compliance data for Biocoat, Inc. in Horsham, Pennsylvania. 1 FDA inspection on record, 1 Form 483, last inspected November 17, 2017.
Company Profile
This profile covers Biocoat, Inc. based in Horsham, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected November 17, 2017.
Most cited issue areas
- Design review - documentation1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1032373 |
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
Biocoat, Inc.
FEI Number
3004462529
Address
211 Witmer Rd, Horsham, Pennsylvania 19044, United States
Country
United States
ID: 32af3a32-1fbc-4d55-8697-7ed30208603a