Cook Inc
Form 483 issued January 26, 2017 · Bloomington, Indiana
- Inspection
- Jan 9 – Jan 26, 2017
- Investigators
- Debara Reese· Sargum C. Sood
- Observations
- 11
- Pages
- 18
- FEI number
- 1820334
In short: On January 26, 2017, FDA issued a Form 483 with 11 observations to Cook Inc in Bloomington, Indiana (FEI 1820334) after an inspection that ran Jan 9 – Jan 26, 2017. The investigators were Debara Reese and Sargum C. Sood. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Production & process controls and capa account for 8 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have…
- 02
Procedures for corrective and preventive action…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 04
Procedures to ensure sampling methods are adequate for their intended use…
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 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cook Inc?
FDA listed 11 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Cook Inc?
Debara Reese and Sargum C. Sood are named on this Form 483, for the inspection of Jan 9 – Jan 26, 2017. Each investigator has a profile showing what they cite most.
When was Cook Inc inspected by FDA?
The inspection ran Jan 9 – Jan 26, 2017, and the Form 483 is dated January 26, 2017.
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.