Genesis BPS, LLC
FDA inspection history across 2 sites, 2013 to 2017
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2013: one warning letter; 2016: one close-out letter; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One warning letter, at Hackensack, New Jersey.
- 2016–17One close-out letter and one Form 483, at Ramsey, New Jersey.
Cited most
Across all Genesis BPS 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 820.198(a)Complaint files1
- 21 CFR 820.30(g)Design controls1
- 21 CFR 820.40(a)Document controls1
The complete Genesis BPS 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
Ramsey, New Jersey
One Form 483 and one close-out letter · 2016 to 2017 · 4 observations
Latest: Form 483, Nov 20, 2017 →Hackensack, New Jersey
One warning letter · 2013
Latest: Warning letter, Jun 12, 2013 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-11-20 | 483 Form 483 | Ramsey, New Jersey | 4 | $99 |
| 2016-03-11 | Close-out Close-out letter | Ramsey, New Jersey | — | $99 |
| 2013-06-12 | Warning letter Warning letter | Hackensack, New Jersey | — | $99 |
Investigators on these documents
FEI number 1000527169 · most recent document Nov 20, 2017
About Genesis BPS, LLC
How many FDA Form 483s has Genesis BPS, LLC received?
FDA Intel has 1 Form 483 on file for Genesis BPS, LLC; the most recent is dated Nov 20, 2017.
When was Genesis BPS, LLC last inspected by FDA?
The most recent FDA inspection document on file for Genesis BPS, LLC is a Form 483 dated Nov 20, 2017, for the site in Ramsey, New Jersey.
What did FDA cite at Genesis BPS, LLC?
The regulations cited most in the observations on file for Genesis BPS, LLC 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 820.198(a) (Complaint files), 1 time; 21 CFR 820.30(g) (Design controls), 1 time.
Has Genesis BPS, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Genesis BPS, LLC; the most recent is dated Jun 12, 2013.