GenTrac Inc.
Form 483 issued September 12, 2019 · Middleton, Wisconsin
- Inspection
- Sep 4 – Sep 12, 2019
- Investigators
- Debra M. Emerson· Peter S. Kessler· Ze Peng
- Observations
- 6
- Pages
- 4
- FEI number
- 3002919848
In short: On September 12, 2019, FDA issued a Form 483 with 6 observations to GenTrac Inc. in Middleton, Wisconsin (FEI 3002919848) after an inspection that ran Sep 4 – Sep 12, 2019. The investigators were Debra M. Emerson, Peter S. Kessler and Ze Peng. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The cleaning/regeneration procedure of the (b) (4) listed in SOP-44880 Operation of the OMY ' Chromatography…
- 03
The procedures to ensure the control and accountability of stability…
- 04
The following gaps were identified during the review of event PR 2575906 which was opened on…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmGenTrac Inc. history
The site's inspection history, in date order.
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 GenTrac Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected GenTrac Inc.?
Debra M. Emerson, Peter S. Kessler and Ze Peng are named on this Form 483, for the inspection of Sep 4 – Sep 12, 2019. Each investigator has a profile showing what they cite most.
When was GenTrac Inc. inspected by FDA?
The inspection ran Sep 4 – Sep 12, 2019, and the Form 483 is dated September 12, 2019.
How do I get the full Form 483 for GenTrac Inc.?
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