United-Guardian, Inc.
Form 483 issued August 2, 2018 · Hauppauge, New York
- Inspection
- Jul 24 – Aug 2, 2018
- Investigators
- Jony Mathews· Logy George· Sony Mathews
- Observations
- 9
- Pages
- 6
- FEI number
- 2410853
In short: On August 2, 2018, FDA issued a Form 483 with 9 observations to United-Guardian, Inc. in Hauppauge, New York (FEI 2410853) after an inspection that ran Jul 24 – Aug 2, 2018. The investigators were Jony Mathews, Logy George and Sony Mathews. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Laboratory controls and facilities & equipment account for 6 of 9 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
This inspection in context
Jony Mathews
1 document · 2018
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmUnited-Guardian, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at United-Guardian, Inc.?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected United-Guardian, Inc.?
Jony Mathews, Logy George and Sony Mathews are named on this Form 483, for the inspection of Jul 24 – Aug 2, 2018. Each investigator has a profile showing what they cite most.
When was United-Guardian, Inc. inspected by FDA?
The inspection ran Jul 24 – Aug 2, 2018, and the Form 483 is dated August 2, 2018.
How do I get the full Form 483 for United-Guardian, 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.