BIC Graphic USA Manufacturing Co., Inc
Form 483 issued November 17, 2016 · Red Wing, Minnesota
- Inspection
- Nov 15 – Nov 17, 2016
- Investigator
- Anthony Ladner
- Observations
- 2
- Pages
- 1
- FEI number
- 2111760
In short: On November 17, 2016, FDA issued a Form 483 with 2 observations to BIC Graphic USA Manufacturing Co., Inc in Red Wing, Minnesota (FEI 2111760) after an inspection that ran Nov 15 – Nov 17, 2016. The investigator was Anthony Ladner. Most observations concern packaging & labeling and quality system; the most-cited regulation is 21 CFR 211.125 (labeling issuance).
At a glance
Packaging & labeling and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.125(f) (1×) · 211.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing in sufficient detail the controls employed for the issuance of…
- 02
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Anthony Ladner
10 documents · 2016–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmBIC Graphic USA Manufacturing Co., Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.125(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BIC Graphic USA Manufacturing Co., Inc?
FDA listed 2 observations on this Form 483, mostly about packaging & labeling and quality system. The most-cited regulation is 21 CFR 211.125 (labeling issuance). The opening words of each observation are shown on this page.
Who inspected BIC Graphic USA Manufacturing Co., Inc?
Anthony Ladner is named on this Form 483, for the inspection of Nov 15 – Nov 17, 2016. Each investigator has a profile showing what they cite most.
When was BIC Graphic USA Manufacturing Co., Inc inspected by FDA?
The inspection ran Nov 15 – Nov 17, 2016, and the Form 483 is dated November 17, 2016.
How do I get the full Form 483 for BIC Graphic USA Manufacturing Co., 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.