Bell Pharmaceuticals
Form 483 issued November 20, 2015 · Belle Plaine, Minnesota
- Inspection
- Nov 17 – Nov 20, 2015
- Investigators
- Courtney R. Tiegs· Shalonda C. Clifford
- Observations
- 4
- Pages
- 2
- FEI number
- 2123499
In short: On November 20, 2015, FDA issued a Form 483 with 4 observations to Bell Pharmaceuticals in Belle Plaine, Minnesota (FEI 2123499) after an inspection that ran Nov 17 – Nov 20, 2015. The investigators were Courtney R. Tiegs and Shalonda C. Clifford. Most observations concern packaging & labeling and production.
At a glance
Observations span 4 systems, led by packaging & labeling.
What FDA observed
Preview: the opening words of each observation- 01
Access to the storage area for labels and labeling materials is not…
- 02
Batch production and control records do not include complete information relating to the production and control…
- 0321 CFR 211.25(a)21 CFR 210
Employees are not given training in the particular operations they perform as part…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
This inspection in context
Courtney R. Tiegs
1 document · 2015
Cites 210 more than any other section. Most of their documents are for sites in Minnesota.
The firmBell Pharmaceuticals history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.122(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bell Pharmaceuticals?
FDA listed 4 observations on this Form 483, mostly about packaging & labeling, production and quality system. The opening words of each observation are shown on this page.
Who inspected Bell Pharmaceuticals?
Courtney R. Tiegs and Shalonda C. Clifford are named on this Form 483, for the inspection of Nov 17 – Nov 20, 2015. Each investigator has a profile showing what they cite most.
When was Bell Pharmaceuticals inspected by FDA?
The inspection ran Nov 17 – Nov 20, 2015, and the Form 483 is dated November 20, 2015.
How do I get the full Form 483 for Bell Pharmaceuticals?
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.