B. Braun US Pharmaceutical Manufacturing LLC
Form 483 issued October 30, 2020 · Daytona Beach, Florida
- Inspection
- Oct 19 – Oct 30, 2020
- Investigators
- Ileana Barreto-Pettit· Jessica L. Pressley
- Observations
- 9
- Pages
- 7
- FEI number
- 3014200891
In short: On October 30, 2020, FDA issued a Form 483 with 9 observations to B. Braun US Pharmaceutical Manufacturing LLC in Daytona Beach, Florida (FEI 3014200891) after an inspection that ran Oct 19 – Oct 30, 2020. The investigators were Ileana Barreto-Pettit and Jessica L. Pressley. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.68 (2×)
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…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
The control systems necessary to prevent contamination…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmB. Braun US Pharmaceutical Manufacturing LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at B. Braun US Pharmaceutical Manufacturing LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected B. Braun US Pharmaceutical Manufacturing LLC?
Ileana Barreto-Pettit and Jessica L. Pressley are named on this Form 483, for the inspection of Oct 19 – Oct 30, 2020. Each investigator has a profile showing what they cite most.
When was B. Braun US Pharmaceutical Manufacturing LLC inspected by FDA?
The inspection ran Oct 19 – Oct 30, 2020, and the Form 483 is dated October 30, 2020.
How do I get the full Form 483 for B. Braun US Pharmaceutical Manufacturing LLC?
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.