G.C. Hanford Manufacturing Company
Form 483 issued April 23, 2015 · Syracuse, New York
- Inspection
- Apr 20 – Apr 23, 2015
- Investigators
- Kenneth G. Klobus· Sasha M. Latonis
- Observations
- 2
- Pages
- 1
- FEI number
- 3008742888
In short: On April 23, 2015, FDA issued a Form 483 with 2 observations to G.C. Hanford Manufacturing Company in Syracuse, New York (FEI 3008742888) after an inspection that ran Apr 20 – Apr 23, 2015. The investigators were Kenneth G. Klobus and Sasha M. Latonis. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.188 (1×) · 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records do not include complete information relating to the production and…
- 02
Written procedures for sanitation are not followed…
This inspection in context
Kenneth G. Klobus
1 document · 2015
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in New York.
The firmG.C. Hanford Manufacturing Company history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at G.C. Hanford Manufacturing Company?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected G.C. Hanford Manufacturing Company?
Kenneth G. Klobus and Sasha M. Latonis are named on this Form 483, for the inspection of Apr 20 – Apr 23, 2015. Each investigator has a profile showing what they cite most.
When was G.C. Hanford Manufacturing Company inspected by FDA?
The inspection ran Apr 20 – Apr 23, 2015, and the Form 483 is dated April 23, 2015.
How do I get the full Form 483 for G.C. Hanford Manufacturing Company?
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.