CooperSurgical, Inc.
FDA inspection history across 2 sites, 2015 to 2024
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2015: one warning letter; 2017: one close-out letter; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17One warning letter and one close-out letter, at Stafford, Texas.
- 2022–24Two Form 483s, at North Tonawanda, New York.
- 2022The longest 483 on file: 5 observations over 7 pages at North Tonawanda, New York.
Cited most
Across all CooperSurgical observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.198(b)(2)Complaint files1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
- 21 CFR 820.100Corrective and preventive action1
The complete CooperSurgical 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
North Tonawanda, New York
Two Form 483s · 2022 to 2024 · 7 observations
Latest: Form 483, Feb 1, 2024 →Stafford, Texas
One close-out letter · 2017
Latest: Close-out, Sep 12, 2017 →
Also: one document not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-01 | 483 Form 483 | North Tonawanda, New York | 2 | $99 |
| 2022-03-04 | 483 Form 483 | North Tonawanda, New York | 5 | $99 |
| 2017-09-12 | Close-out Close-out letter | Stafford, Texas | — | $99 |
| 2015-06-09 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 1316626 · most recent document Feb 1, 2024
About CooperSurgical, Inc.
How many FDA Form 483s has CooperSurgical, Inc. received?
FDA Intel has 2 Form 483s on file for CooperSurgical, Inc.; the most recent is dated Feb 1, 2024.
When was CooperSurgical, Inc. last inspected by FDA?
The most recent FDA inspection document on file for CooperSurgical, Inc. is a Form 483 dated Feb 1, 2024, for the site in North Tonawanda, New York.
What did FDA cite at CooperSurgical, Inc.?
The regulations cited most in the observations on file for CooperSurgical, Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.198(b)(2) (Complaint files), 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 Jun 9, 2015.