Company
United StatesMedical Components, Inc dba MedComp, Harleysville, PA – FDA Inspections
Inspection records and compliance data for Medical Components, Inc dba MedComp in Harleysville, Pennsylvania. 6 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected September 23, 2021.
Company Profile
This profile covers Medical Components, Inc dba MedComp based in Harleysville, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 2
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 1
First inspected November 9, 2009. Last inspected September 23, 2021.
Most cited issue areas
- Documentation2 inspections
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Documented evaluation1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 23, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1155357 |
| June 14, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1014083 |
| September 10, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 940916 |
| February 12, 2015 | OAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 916007 |
| March 19, 2012 | NAI | Human Drugs, Medical Devices & Rad Health · Postmarket Assurance: Devices | 774963 |
| November 9, 2009 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 629432 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
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Company Information
Name
Medical Components, Inc dba MedComp
FEI Number
2518902
Address
1499 Delp Dr, Harleysville, Pennsylvania 19438, United States
Country
United States
ID: 24de0555-f79b-48bc-93e9-8b266ba67d44