Honeywell Safety Products
Form 483 issued April 8, 2020 · Platteville, Wisconsin
- Inspection
- Mar 11 – Apr 8, 2020
- Investigator
- Joel D. Hustedt
- Observations
- 2
- Pages
- 2
- FEI number
- 1418051
In short: On April 8, 2020, FDA issued a Form 483 with 2 observations to Honeywell Safety Products in Platteville, Wisconsin (FEI 1418051) after an inspection that ran Mar 11 – Apr 8, 2020. The investigator was Joel D. Hustedt. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.166(a) (1×) · 211.56(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmHoneywell Safety Products history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Honeywell Safety Products?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Honeywell Safety Products?
Joel D. Hustedt is named on this Form 483, for the inspection of Mar 11 – Apr 8, 2020. Each investigator has a profile showing what they cite most.
When was Honeywell Safety Products inspected by FDA?
The inspection ran Mar 11 – Apr 8, 2020, and the Form 483 is dated April 8, 2020.
How do I get the full Form 483 for Honeywell Safety Products?
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.