Ultratab Laboratories, Inc.
Form 483 issued February 1, 2019 · Highland, New York
- Inspection
- Jan 25 – Feb 1, 2019
- Observations
- 1
- Pages
- 2
- FEI number
- 3003068822
In short: On February 1, 2019, FDA issued a Form 483 with 1 observation to Ultratab Laboratories, Inc. in Highland, New York (FEI 3003068822) after an inspection that ran Jan 25 – Feb 1, 2019. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.205 (what is the requirement to establish a master manufacturing record?).
At a glance
1 of 1 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.205(b)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Your master manufacturing record did not identify specifications for the points, steps, or stages in the…
This inspection in context
Questions about this 483
What did FDA find at Ultratab Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.205 (what is the requirement to establish a master manufacturing record?). The opening words of each observation are shown on this page.
When was Ultratab Laboratories, Inc. inspected by FDA?
The inspection ran Jan 25 – Feb 1, 2019, and the Form 483 is dated February 1, 2019.
How do I get the full Form 483 for Ultratab Laboratories, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.