Baxter SA
Form 483 issued September 27, 2019 · Lessines, Belgium
- Inspection
- Sep 19 – Sep 27, 2019
- Investigators
- Julianne C. McCullough· Ofthis Pla Julianne McCullough
- Observations
- 9
- Pages
- 5
- FEI number
- 3005468265
In short: On September 27, 2019, FDA issued a Form 483 with 9 observations to Baxter SA in Lessines, Belgium (FEI 3005468265) after an inspection that ran Sep 19 – Sep 27, 2019. The investigators were Julianne C. McCullough and Ofthis Pla Julianne McCullough. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 6 of 9 observations.
Most cited: 21 CFR 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not always made of investigations into the failure of a batch or any…
- 02
Established laboratory control mechanisms…
- 03
The establishment of laboratory control mechanisms are not drafted by…
- 04
Laboratory controls do not include a description of sampling…
This inspection in context
Julianne C. McCullough
4 documents · 2010–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmBaxter SA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter SA?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Baxter SA?
Julianne C. McCullough and Ofthis Pla Julianne McCullough are named on this Form 483, for the inspection of Sep 19 – Sep 27, 2019. Each investigator has a profile showing what they cite most.
When was Baxter SA inspected by FDA?
The inspection ran Sep 19 – Sep 27, 2019, and the Form 483 is dated September 27, 2019.
How do I get the full Form 483 for Baxter SA?
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.