B & J Group
Form 483 issued October 2, 2023 · Morrisville, Pennsylvania
- Inspection
- Sep 26 – Oct 2, 2023
- Investigator
- Michael Casner
- Observations
- 6
- Pages
- 4
- FEI number
- 3010096700
In short: On October 2, 2023, FDA issued a Form 483 with 6 observations to B & J Group in Morrisville, Pennsylvania (FEI 3010096700) after an inspection that ran Sep 26 – Oct 2, 2023. The investigator was Michael Casner. Most observations concern laboratory controls and materials.
At a glance
Laboratory controls and materials account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Specific identification tests are not conducted on components that have been accepted based on the…
- 03
The calibration of instruments is not done at suitable intervals in accordance with…
- 04
A sample which is representative of each lot in each shipment of each active…
This inspection in context
Michael Casner
3 documents · 2019–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmB & J Group history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at B & J Group?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, materials and quality system. The opening words of each observation are shown on this page.
Who inspected B & J Group?
Michael Casner is named on this Form 483, for the inspection of Sep 26 – Oct 2, 2023. Each investigator has a profile showing what they cite most.
When was B & J Group inspected by FDA?
The inspection ran Sep 26 – Oct 2, 2023, and the Form 483 is dated October 2, 2023.
How do I get the full Form 483 for B & J Group?
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.