Baxter Healthcare Corporation
Form 483 issued July 19, 2024 · Jayuya, Puerto Rico
- Investigators
- Amir Alavi· Santos E. Camara
- Observations
- 6
- Pages
- 7
- FEI number
- 2618677
In short: On July 19, 2024, FDA issued a Form 483 with 6 observations to Baxter Healthcare Corporation in Jayuya, Puerto Rico (FEI 2618677). The investigators were Amir Alavi and Santos E. Camara. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Established test procedures and Laboratory control mechanisms are not documented at…
- 03
Written Records of investigation of a drug complaint do…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
This inspection in context
Amir Alavi
9 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmBaxter Healthcare Corporation history
All 4 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 Baxter Healthcare Corporation?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Baxter Healthcare Corporation?
Amir Alavi and Santos E. Camara are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Baxter Healthcare Corporation inspected by FDA?
This Form 483 is dated July 19, 2024.
How do I get the full Form 483 for Baxter Healthcare 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.