BASF Corporation
Form 483 issued October 23, 2015 · Bishop, Texas
- Inspection
- Oct 19 – Oct 23, 2015
- Investigators
- Shatina R. Alridge· Shelby N. Marler· Unnee Ranjan
- Observations
- 1
- Pages
- 1
- FEI number
- 3001451837
In short: On October 23, 2015, FDA issued a Form 483 with 1 observation to BASF Corporation in Bishop, Texas (FEI 3001451837) after an inspection that ran Oct 19 – Oct 23, 2015. The investigators were Shatina R. Alridge, Shelby N. Marler and Unnee Ranjan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.180 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed for the completion of the (b) (4) Product Review and the…
This inspection in context
Shatina R. Alridge
10 documents · 2015–2020
Cites 110.35 (sanitary operations) more than any other section. Most of their documents are for sites in Texas.
The firmBASF Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BASF Corporation?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected BASF Corporation?
Shatina R. Alridge, Shelby N. Marler and Unnee Ranjan are named on this Form 483, for the inspection of Oct 19 – Oct 23, 2015. Each investigator has a profile showing what they cite most.
When was BASF Corporation inspected by FDA?
The inspection ran Oct 19 – Oct 23, 2015, and the Form 483 is dated October 23, 2015.
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.