Company
United StatesULTRAtab Laboratories, Inc., Highland, NY – FDA Inspections
Inspection records and compliance data for ULTRAtab Laboratories, Inc. in Highland, New York. 10 FDA inspections on record (3 OAI), 2 Form 483s, last inspected September 11, 2023.
Company Profile
This profile covers ULTRAtab Laboratories, Inc. based in Highland, New York, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 3
- VAI
- 7
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected May 5, 2010. Last inspected September 11, 2023.
Most cited issue areas
- Authority lacking to review records, investigate errors2 inspections
- Cleaning / Sanitizing / Maintenance2 inspections
- Computer control of master formula records2 inspections
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 11, 2023 | OAI | Human Drugs · Drug Quality Assurance | 1219486 |
| September 14, 2021 | OAI | Human Drugs · Drug Quality Assurance | 1151570 |
| January 31, 2020 | OAI | Human Drugs · Drug Quality Assurance | 1116566 |
| February 1, 2019 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1078170 |
| September 14, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1065575 |
| December 14, 2015 | VAI | Human Drugs · Drug Quality Assurance | 954453 |
| August 2, 2013 | VAI | Human Drugs · Drug Quality Assurance | 843815 |
| November 15, 2011 | VAI | Human Drugs · Drug Quality Assurance | 755233 |
| August 2, 2011 | VAI | Human Drugs · Drug Quality Assurance | 737695 |
| May 5, 2010 | VAI | Human Drugs · Drug Quality Assurance | 657372 |
FDA documents
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Company Information
Name
ULTRAtab Laboratories, Inc.
FEI Number
3003068822
Address
50 Toc Dr, Highland, New York 12528, United States
Country
United States
ID: 5455d350-8084-4833-9610-a069ea634da7