Ultratab Laboratories, Inc.
Form 483 issued January 31, 2020 · Highland, New York
- Inspection
- Jan 21 – Jan 31, 2020
- Investigator
- Sony Mathews
- Observations
- 7
- Pages
- 8
- FEI number
- 3003068822
In short: On January 31, 2020, FDA issued a Form 483 with 7 observations to Ultratab Laboratories, Inc. in Highland, New York (FEI 3003068822) after an inspection that ran Jan 21 – Jan 31, 2020. The investigator was Sony Mathews. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.68(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to fully investigate…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 04
Input to and output from the computer and related systems of formulas are not checked for…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmUltratab Laboratories, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ultratab Laboratories, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Ultratab Laboratories, Inc.?
Sony Mathews is named on this Form 483, for the inspection of Jan 21 – Jan 31, 2020. Each investigator has a profile showing what they cite most.
When was Ultratab Laboratories, Inc. inspected by FDA?
The inspection ran Jan 21 – Jan 31, 2020, and the Form 483 is dated January 31, 2020.
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.