Company
United StatesSklar Instruments, West Chester, PA – FDA Inspections
Inspection records and compliance data for Sklar Instruments in West Chester, Pennsylvania. 3 FDA inspections on record, 1 Form 483, last inspected November 09, 2018.
Company Profile
This profile covers Sklar Instruments based in West Chester, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 30, 2011. Last inspected November 9, 2018.
Most cited issue areas
- Design input - documentation1 inspection
- DHR content1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 9, 2018 | Not classified | Medical Devices & Rad Health | 1105796 |
| August 3, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 936721 |
| September 30, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 747975 |
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
Sklar Instruments
FEI Number
2523865
Address
1333 Lenape Rd, West Chester, Pennsylvania 19382, United States
Country
United States
ID: 8afc7560-be77-4f92-aa4b-daedabfd5c1b