B. Braun Medical Inc
Form 483 issued June 29, 2018 · Irvine, California
- Inspection
- Jun 4 – Jun 29, 2018
- Investigators
- Amanda L. Fyles· Carrie A. Hughes· Evelyn Wong
- Observations
- 8
- Pages
- 10
- FEI number
- 2021236
In short: On June 29, 2018, FDA issued a Form 483 with 8 observations to B. Braun Medical Inc in Irvine, California (FEI 2021236) after an inspection that ran Jun 4 – Jun 29, 2018. The investigators were Amanda L. Fyles, Carrie A. Hughes, Evelyn Wong and Walden H. Lee. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records are deficient in that they do not include a complete record of all…
- 02
The accuracy and specificity oftest methods have not…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Amanda L. Fyles
5 documents · 2017–2019
Cites 211.165 (testing and release for distribution) 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 211.194(a)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at B. Braun Medical Inc?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected B. Braun Medical Inc?
Amanda L. Fyles, Carrie A. Hughes, Evelyn Wong and Walden H. Lee are named on this Form 483, for the inspection of Jun 4 – Jun 29, 2018. Each investigator has a profile showing what they cite most.
When was B. Braun Medical Inc inspected by FDA?
The inspection ran Jun 4 – Jun 29, 2018, and the Form 483 is dated June 29, 2018.
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.