Company
United StatesRIJ Pharmaceutical LLC, Middletown, NY – FDA Inspections
Inspection records and compliance data for RIJ Pharmaceutical LLC in Middletown, New York. 4 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected April 13, 2018.
Company Profile
This profile covers RIJ Pharmaceutical LLC based in Middletown, New York, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected May 27, 2010. Last inspected April 13, 2018.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Absence of Written Procedures1 inspection
- Adequate number of batches on stability1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 13, 2018 | OAI | Human Drugs · Drug Quality Assurance | 1048639 |
| October 30, 2015 | VAI | Human Drugs · Drug Quality Assurance | 948378 |
| May 2, 2011 | NAI | Human Drugs · Drug Quality Assurance | 723513 |
| May 27, 2010 | VAI | Human Drugs · Drug Quality Assurance | 669871 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
RIJ Pharmaceutical LLC
FEI Number
1000120212
Address
40 Commercial Ave, Middletown, New York 10941, United States
Country
United States
ID: 80a63e4c-5df4-4e65-9124-341e9b7c39ee