BASF Corporation
Form 483 issued November 17, 2017 · East Setauket, New York
- Inspection
- Nov 7 – Nov 17, 2017
- Investigator
- Mindy M. Chou
- Observations
- 4
- Pages
- 3
- FEI number
- 1000521506
In short: On November 17, 2017, FDA issued a Form 483 with 4 observations to BASF Corporation in East Setauket, New York (FEI 1000521506) after an inspection that ran Nov 7 – Nov 17, 2017. The investigator was Mindy M. Chou. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) 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 211.192
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 quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected BASF Corporation?
Mindy M. Chou is named on this Form 483, for the inspection of Nov 7 – Nov 17, 2017. Each investigator has a profile showing what they cite most.
When was BASF Corporation inspected by FDA?
The inspection ran Nov 7 – Nov 17, 2017, and the Form 483 is dated November 17, 2017.
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.