Ashland LLC
Form 483 issued November 21, 2017 · Bridgewater, New Jersey
- Inspection
- Nov 7 – Nov 21, 2017
- Investigator
- Esteban Beltran
- Observations
- 6
- Pages
- 6
- FEI number
- 1000122243
In short: On November 21, 2017, FDA issued a Form 483 with 6 observations to Ashland LLC in Bridgewater, New Jersey (FEI 1000122243) after an inspection that ran Nov 7 – Nov 21, 2017. The investigator was Esteban Beltran. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Validation of device software…
- 02
Procedures for design change…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
The equipment used in the manufacturing process does…
This inspection in context
Esteban Beltran
9 documents · 2017–2025
Cites 820.70(a) (production and process controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmAshland LLC history
All 2 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 Ashland LLC?
FDA listed 6 observations on this Form 483, mostly about design controls, production & process controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Ashland LLC?
Esteban Beltran is named on this Form 483, for the inspection of Nov 7 – Nov 21, 2017. Each investigator has a profile showing what they cite most.
When was Ashland LLC inspected by FDA?
The inspection ran Nov 7 – Nov 21, 2017, and the Form 483 is dated November 21, 2017.
How do I get the full Form 483 for Ashland 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.