Company
United StatesHercon Pharmaceuticals, LLC, Emigsville, PA – FDA Inspections
Inspection records and compliance data for Hercon Pharmaceuticals, LLC in Emigsville, Pennsylvania. 6 FDA inspections on record, 2 Form 483s, last inspected April 05, 2019.
Company Profile
This profile covers Hercon Pharmaceuticals, LLC based in Emigsville, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected November 17, 2009. Last inspected April 5, 2019.
Most cited issue areas
- Investigations of discrepancies, failures3 inspections
- Calibration/Inspection/Checking not done2 inspections
- Lab controls established, including changes2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 5, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1085238 |
| April 28, 2017 | Not classified | Human Drugs · Drug Quality Assurance | 1012285 |
| August 26, 2016 | VAI | Human Drugs · Drug Quality Assurance | 983439 |
| July 23, 2012 | VAI | Human Drugs · Drug Quality Assurance | 793319 |
| July 26, 2011 | VAI | Human Drugs · Drug Quality Assurance | 737145 |
| November 17, 2009 | NAI | Human Drugs · Drug Quality Assurance | 632078 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hercon Pharmaceuticals, LLC
FEI Number
2522638
Address
101 Aberdeen Rd, Emigsville, Pennsylvania 17318, United States
Country
United States
ID: fec71b58-f9ca-4d72-a14a-c02da0a17760