Cook Inc
FDA inspection history in Bloomington, Indiana, 2014 to 2020
- 2
- Form 483s
- 2
- Close-outs
Every document, by year
- Form 483
- Close-out
2014: one close-out letter; 2017: one Form 483; 2018: one close-out letter; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One close-out letter, at Bloomington, Indiana.
- 2017–20Two Form 483s and one close-out letter, at Bloomington, Indiana.
- 2017The longest 483 on file: 11 observations over 18 pages at Bloomington, Indiana.
Cited most
Across all Cook observations on file
- 21 CFR 820.30(d)Design controls3
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 820.70(a)Production and process controls2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
The complete Cook file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Bloomington, Indiana
Two Form 483s and two close-out letters · 2014 to 2020 · 15 observations
Latest: Form 483, Feb 7, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-02-07 | 483 Form 483 | Bloomington, Indiana | 4 | $99 |
| 2018-09-04 | Close-out Close-out letter | Bloomington, Indiana | — | $99 |
| 2017-01-26 | 483 Form 483 | Bloomington, Indiana | 11 | $99 |
| 2014-09-16 | Close-out Close-out letter | Bloomington, Indiana | — | $99 |
Investigators on these documents
FEI number 1820334 · most recent document Feb 7, 2020
About Cook Inc
How many FDA Form 483s has Cook Inc received?
FDA Intel has 2 Form 483s on file for Cook Inc; the most recent is dated Feb 7, 2020.
When was Cook Inc last inspected by FDA?
The most recent FDA inspection document on file for Cook Inc is a Form 483 dated Feb 7, 2020, for the site in Bloomington, Indiana.
What did FDA cite at Cook Inc?
The regulations cited most in the observations on file for Cook Inc are 21 CFR 820.30(d) (Design controls), 3 times; 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 820.198(a) (Complaint files), 2 times.