CooperSurgical, Inc.
FDA inspection history in Trumbull, Connecticut, 2021
- 1
- Form 483
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2021: one Form 483 and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483 and one warning letter, at Trumbull, Connecticut.
Cited most
Across all CooperSurgical observations on file
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.120(d)Device labeling1
- 21 CFR 820.70(c)Production and process controls1
- 21 CFR 820.90(b)(1)Nonconforming product1
The complete CooperSurgical file.
All 3 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
Trumbull, Connecticut
One Form 483, one warning letter and one close-out letter · 2021 · 4 observations
Latest: Form 483, Jul 15, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-07-15 | 483 Form 483 | Trumbull, Connecticut | 4 | $99 |
| 2021-02-12 | Warning letter Warning letter | Trumbull, Connecticut | — | $99 |
| Undated | Close-out Close-out letter | Trumbull, Connecticut | — | $99 |
Investigators on these documents
FEI number 1216677 · most recent document Jul 15, 2021
About CooperSurgical, Inc.
How many FDA Form 483s has CooperSurgical, Inc. received?
FDA Intel has 1 Form 483 on file for CooperSurgical, Inc.; the most recent is dated Jul 15, 2021.
When was CooperSurgical, Inc. last inspected by FDA?
The most recent FDA inspection document on file for CooperSurgical, Inc. is a Form 483 dated Jul 15, 2021, for the site in Trumbull, Connecticut.
What did FDA cite at CooperSurgical, Inc.?
The regulations cited most in the observations on file for CooperSurgical, Inc. are 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.120(d) (Device labeling), 1 time; 21 CFR 820.70(c) (Production and process controls), 1 time.
Has CooperSurgical, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for CooperSurgical, Inc.; the most recent is dated Feb 12, 2021.