Ashland LLC
Amended 483 issued August 7, 2025 · Bridgewater, New Jersey
- Inspection
- Aug 4 – Aug 7, 2025
- Investigator
- William R. Chang
- Observations
- 5
- Pages
- 5
- FEI number
- 1000122243
In short: On August 7, 2025, FDA issued a Amended 483 with 5 observations to Ashland LLC in Bridgewater, New Jersey (FEI 1000122243) after an inspection that ran Aug 4 – Aug 7, 2025. The investigator was William R. Chang. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure equipment is routinely calibrated and inspected have…
- 02
Procedures for corrective and preventive action have…
- 03
Risk analysis is…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
1 more observation
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
William R. Chang
5 documents · 2019–2025
Cites 820.30 (design 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 documentsOther sites cited under 820.72(a)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Ashland LLC?
FDA listed 5 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Ashland LLC?
William R. Chang is named on this Amended 483, for the inspection of Aug 4 – Aug 7, 2025. Each investigator has a profile showing what they cite most.
When was Ashland LLC inspected by FDA?
The inspection ran Aug 4 – Aug 7, 2025, and the Amended 483 is dated August 7, 2025.
How do I get the full Amended 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.