B & J Group
FDA inspection history in Morrisville, Pennsylvania, 2023
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2023: one Form 483 and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483 and one warning letter, at Morrisville, Pennsylvania.
Cited most
Across all B & J Group observations on file
- 21 CFR 211.160(b)(4)General requirements1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.170(a)Reserve samples1
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.188(b)(11)Batch production and control records1
The complete B & J Group 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
Morrisville, Pennsylvania
One Form 483 and one warning letter · 2023 · 6 observations
Latest: Form 483, Oct 2, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-02 | 483 Form 483 | Morrisville, Pennsylvania | 6 | $99 |
| 2023-01-19 | Warning letter Warning letter | Morrisville, Pennsylvania | — | $99 |
Investigators on these documents
FEI number 3010096700 · most recent document Oct 2, 2023
About B & J Group
How many FDA Form 483s has B & J Group received?
FDA Intel has 1 Form 483 on file for B & J Group; the most recent is dated Oct 2, 2023.
When was B & J Group last inspected by FDA?
The most recent FDA inspection document on file for B & J Group is a Form 483 dated Oct 2, 2023, for the site in Morrisville, Pennsylvania.
What did FDA cite at B & J Group?
The regulations cited most in the observations on file for B & J Group are 21 CFR 211.160(b)(4) (General requirements), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time; 21 CFR 211.170(a) (Reserve samples), 1 time.
Has B & J Group received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for B & J Group; the most recent is dated Jan 19, 2023.