BASF Corporation
Form 483 issued May 29, 2025 · East Setauket, New York
- Inspection
- May 16 – May 29, 2025
- Investigators
- Chelsea W. Lamm· Corrine M. Carter· Orrine Arter
- Observations
- 4
- Pages
- 18
- FEI number
- 1000521506
In short: On May 29, 2025, FDA issued a Form 483 with 4 observations to BASF Corporation in East Setauket, New York (FEI 1000521506) after an inspection that ran May 16 – May 29, 2025. The investigators were Chelsea W. Lamm, Corrine M. Carter and Orrine Arter. Most observations concern gLP; the most-cited regulation is 21 CFR 58.81 (standard operating procedures).
At a glance
4 of 4 observations on this 483 concern glp.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality assurance unit failed to review the final study report to assure that the reported…
- 02
Not all deviations from standard operating procedures in a study were authorized by the study director…
- 03
The study director failed to assure that all raw data and documentation were transferred to the…
- 04
Not all electronic systems used in the conduct of Animal Rule…
This inspection in context
Chelsea W. Lamm
1 document · 2025
Cites 58.190 (storage and retrieval of records and data) more than any other section. Most of their documents are for sites in New York.
The firmBASF Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 58.35
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BASF Corporation?
FDA listed 4 observations on this Form 483, mostly about gLP. The most-cited regulation is 21 CFR 58.81 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected BASF Corporation?
Chelsea W. Lamm, Corrine M. Carter and Orrine Arter are named on this Form 483, for the inspection of May 16 – May 29, 2025. Each investigator has a profile showing what they cite most.
When was BASF Corporation inspected by FDA?
The inspection ran May 16 – May 29, 2025, and the Form 483 is dated May 29, 2025.
How do I get the full Form 483 for BASF Corporation?
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.