Bella Pharmaceuticals, Inc.
Form 483 issued July 18, 2017 · Chicago, Illinois
- Inspection
- Jul 18, 2017
- Investigator
- Brian D. Nicholson
- Observations
- 11
- Pages
- 8
- FEI number
- 3013442632
In short: On July 18, 2017, FDA issued a Form 483 with 11 observations to Bella Pharmaceuticals, Inc. in Chicago, Illinois (FEI 3013442632) after an inspection that ran Jul 18, 2017. The investigator was Brian D. Nicholson. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products required to be sterile are not…
- 02
Your firm did not maintain documented production worksheets for any of the compounded sterile drug products…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmBella Pharmaceuticals, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bella Pharmaceuticals, Inc.?
FDA listed 11 observations on this Form 483, mostly about production, facilities & equipment and packaging & labeling. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Bella Pharmaceuticals, Inc.?
Brian D. Nicholson is named on this Form 483, for the inspection of Jul 18, 2017. Each investigator has a profile showing what they cite most.
When was Bella Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jul 18, 2017, and the Form 483 is dated July 18, 2017.
How do I get the full Form 483 for Bella Pharmaceuticals, 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.