Beckton Dickinson and Co
Form 483 issued August 11, 2016 · Columbus, Nebraska
- Inspection
- Aug 8 – Aug 11, 2016
- Observations
- 2
- Pages
- 2
- FEI number
- 1911916
In short: On August 11, 2016, FDA issued a Form 483 with 2 observations to Beckton Dickinson and Co in Columbus, Nebraska (FEI 1911916) after an inspection that ran Aug 8 – Aug 11, 2016. Most observations concern production & process controls and records & documents; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and records & documents account for 2 of 2 observations.
Most cited: 21 CFR 820.70 (1×) · 820.184 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Changes to software used as part of production were not adequately validated…
- 02
The device history record does not demonstrate the device is manufactured in accordance with…
This inspection in context
Questions about this 483
What did FDA find at Beckton Dickinson and Co?
FDA listed 2 observations on this Form 483, mostly about production & process controls and records & documents. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
When was Beckton Dickinson and Co inspected by FDA?
The inspection ran Aug 8 – Aug 11, 2016, and the Form 483 is dated August 11, 2016.
How do I get the full Form 483 for Beckton Dickinson and Co?
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.