Genesis BPS, LLC
Form 483 issued November 20, 2017 · Ramsey, New Jersey
- Inspection
- Nov 1 – Nov 20, 2017
- Investigator
- Melissa A. Freeman
- Observations
- 4
- Pages
- 4
- FEI number
- 1000527169
In short: On November 20, 2017, FDA issued a Form 483 with 4 observations to Genesis BPS, LLC in Ramsey, New Jersey (FEI 1000527169) after an inspection that ran Nov 1 – Nov 20, 2017. The investigator was Melissa A. Freeman. Most observations concern cAPA and design controls.
At a glance
CAPA and design controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The design was not validated under defined operating conditions and using initial production units, lots or…
- 02
Written MDR procedures have not…
- 03
Complaint files are not…
- 04
Documents were not reviewed and not approved by designated individual(s)…
This inspection in context
Melissa A. Freeman
2 documents · 2017
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in New Jersey.
The firmGenesis BPS, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genesis BPS, LLC?
FDA listed 4 observations on this Form 483, mostly about cAPA, design controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Genesis BPS, LLC?
Melissa A. Freeman is named on this Form 483, for the inspection of Nov 1 – Nov 20, 2017. Each investigator has a profile showing what they cite most.
When was Genesis BPS, LLC inspected by FDA?
The inspection ran Nov 1 – Nov 20, 2017, and the Form 483 is dated November 20, 2017.
How do I get the full Form 483 for Genesis BPS, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.