Company
United StatesSpecGx, LLC, Hobart, NY – FDA Inspections
Inspection records and compliance data for SpecGx, LLC in Hobart, New York. 7 FDA inspections on record, 1 Form 483, last inspected January 17, 2025.
Company Profile
This profile covers SpecGx, LLC based in Hobart, New York, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 27, 2010. Last inspected January 17, 2025.
Most cited issue areas
- Cleaning / Sanitizing / Maintenance3 inspections
- Establishment of time limitations2 inspections
- Accurate reproduction included1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 17, 2025 | Not classified | Human Drugs · Drug Quality Assurance | 1256233 |
| March 13, 2020 | NAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 1122931 |
| April 6, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1049694 |
| January 29, 2016 | VAI | Human Drugs · Drug Quality Assurance | 957282 |
| August 30, 2013 | VAI | Human Drugs · Drug Quality Assurance | 846761 |
| April 20, 2012 | VAI | Human Drugs · Drug Quality Assurance | 777958 |
| January 27, 2010 | VAI | Human Drugs · Drug Quality Assurance | 646935 |
FDA documents
Form 483s (1)
People (2)
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Company Information
Name
SpecGx, LLC
FEI Number
1317295
Address
172 Railroad Ave, Hobart, New York 13788, United States
Country
United States
ID: bb0acdf8-ddfa-47bf-b3d6-b97cc5f27b01