Thornton Industries, Inc
Form 483 issued March 4, 2020 · Morris, Illinois
- Inspection
- Mar 3 – Mar 4, 2020
- Investigator
- Brian D. Nicholson
- Observations
- 4
- Pages
- 2
- FEI number
- 3002837627
In short: On March 4, 2020, FDA issued a Form 483 with 4 observations to Thornton Industries, Inc in Morris, Illinois (FEI 3002837627) after an inspection that ran Mar 3 – Mar 4, 2020. The investigator was Brian D. Nicholson. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Sampling and testing plans for drug products are not described in written procedures which include the…
- 02
The in process control procedures were deficient in that they did not include an examination of…
- 03
Access to the storage area for labels and labeling materials is not…
- 04
Specific identification tests are not conducted on components that have been accepted based on the…
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 firmThornton Industries, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Thornton Industries, Inc?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, production and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Thornton Industries, Inc?
Brian D. Nicholson is named on this Form 483, for the inspection of Mar 3 – Mar 4, 2020. Each investigator has a profile showing what they cite most.
When was Thornton Industries, Inc inspected by FDA?
The inspection ran Mar 3 – Mar 4, 2020, and the Form 483 is dated March 4, 2020.
How do I get the full Form 483 for Thornton Industries, 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.