Becton Dickinson and Company
Form 483 issued December 14, 2018 · Sandy, Utah
- Inspection
- Dec 10 – Dec 14, 2018
- Investigator
- Erika V. Butler
- Observations
- 7
- Pages
- 5
- FEI number
- 1710034
In short: On December 14, 2018, FDA issued a Form 483 with 7 observations to Becton Dickinson and Company in Sandy, Utah (FEI 1710034) after an inspection that ran Dec 10 – Dec 14, 2018. The investigator was Erika V. Butler. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 5 of 7 observations.
Most cited: 21 CFR 211.192 (3×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Established laboratory control mechanisms…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmBecton Dickinson and Company history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Becton Dickinson and Company?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Becton Dickinson and Company?
Erika V. Butler is named on this Form 483, for the inspection of Dec 10 – Dec 14, 2018. Each investigator has a profile showing what they cite most.
When was Becton Dickinson and Company inspected by FDA?
The inspection ran Dec 10 – Dec 14, 2018, and the Form 483 is dated December 14, 2018.
How do I get the full Form 483 for Becton Dickinson and Company?
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.