Beckman Coulter, Inc.
FDA inspection history in Miami, Florida, 2011 to 2017
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2011: one warning letter; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter, at Miami, Florida.
- 2017One Form 483, at Miami, Florida.
Cited most
Across all Beckman Coulter observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(c)Complaint files1
- 21 CFR 820.200(a)Servicing1
The complete Beckman Coulter file.
All 2 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
Miami, Florida
One Form 483 and one warning letter · 2011 to 2017 · 4 observations
Latest: Form 483, Oct 16, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-10-16 | 483 Form 483 | Miami, Florida | 4 | $99 |
| 2011-11-01 | Warning letter Warning letter | Miami, Florida | — | $99 |
Investigators on these documents
FEI number 3000203293 · most recent document Oct 16, 2017
About Beckman Coulter, Inc.
How many FDA Form 483s has Beckman Coulter, Inc. received?
FDA Intel has 1 Form 483 on file for Beckman Coulter, Inc.; the most recent is dated Oct 16, 2017.
When was Beckman Coulter, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Beckman Coulter, Inc. is a Form 483 dated Oct 16, 2017, for the site in Miami, Florida.
What did FDA cite at Beckman Coulter, Inc.?
The regulations cited most in the observations on file for Beckman Coulter, Inc. are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(c) (Complaint files), 1 time.
Has Beckman Coulter, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Beckman Coulter, Inc.; the most recent is dated Nov 1, 2011.