B. Braun Medical Inc
Form 483 issued July 23, 2020 · Irvine, California
- Inspection
- Jun 22 – Jul 23, 2020
- Investigators
- Uttaniti Limchumroon· Walden H. Lee
- Observations
- 3
- Pages
- 9
- FEI number
- 2021236
In short: On July 23, 2020, FDA issued a Form 483 with 3 observations to B. Braun Medical Inc in Irvine, California (FEI 2021236) after an inspection that ran Jun 22 – Jul 23, 2020. The investigators were Uttaniti Limchumroon and Walden H. Lee. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 03
Equipment surfaces that contact components are reactive, additive or absorptive so as to alter the safety…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmB. Braun Medical Inc history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at B. Braun Medical Inc?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected B. Braun Medical Inc?
Uttaniti Limchumroon and Walden H. Lee are named on this Form 483, for the inspection of Jun 22 – Jul 23, 2020. Each investigator has a profile showing what they cite most.
When was B. Braun Medical Inc inspected by FDA?
The inspection ran Jun 22 – Jul 23, 2020, and the Form 483 is dated July 23, 2020.
How do I get the full Form 483 for B. Braun Medical Inc?
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.