Cook Inc
Form 483 issued February 7, 2020 · Bloomington, Indiana
- Inspection
- Jan 27 – Feb 7, 2020
- Investigators
- Debara Reese· Taimane J. Fisher
- Observations
- 4
- Pages
- 5
- FEI number
- 1820334
In short: On February 7, 2020, FDA issued a Form 483 with 4 observations to Cook Inc in Bloomington, Indiana (FEI 1820334) after an inspection that ran Jan 27 – Feb 7, 2020. The investigators were Debara Reese and Taimane J. Fisher. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for collective and preventive action have…
- 02
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Labeling and packaging operations were not controlled…
This inspection in context
Debara Reese
6 documents · 2015–2023
Cites 820.75(a) (process validation) more than any other section. Most of their documents are for sites in Indiana.
The firmCook 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 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cook Inc?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Cook Inc?
Debara Reese and Taimane J. Fisher are named on this Form 483, for the inspection of Jan 27 – Feb 7, 2020. Each investigator has a profile showing what they cite most.
When was Cook Inc inspected by FDA?
The inspection ran Jan 27 – Feb 7, 2020, and the Form 483 is dated February 7, 2020.
How do I get the full Form 483 for Cook 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.