Ultratab Laboratories, Inc.
Form 483 issued September 14, 2021 · Highland, New York
- Inspection
- Aug 16 – Sep 14, 2021
- Investigators
- Brandy N. Lepage· Sony Mathews
- Observations
- 3
- Pages
- 7
- FEI number
- 3003068822
In short: On September 14, 2021, FDA issued a Form 483 with 3 observations to Ultratab Laboratories, Inc. in Highland, New York (FEI 3003068822) after an inspection that ran Aug 16 – Sep 14, 2021. The investigators were Brandy N. Lepage and Sony Mathews. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 03
Records are not kept for the cleaning…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ultratab Laboratories, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Ultratab Laboratories, Inc.?
Brandy N. Lepage and Sony Mathews are named on this Form 483, for the inspection of Aug 16 – Sep 14, 2021. Each investigator has a profile showing what they cite most.
When was Ultratab Laboratories, Inc. inspected by FDA?
The inspection ran Aug 16 – Sep 14, 2021, and the Form 483 is dated September 14, 2021.
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.