Diabetes Corporation of America
Form 483 issued August 20, 2015 · Franklin, Tennessee
- Inspection
- Aug 11 – Aug 20, 2015
- Investigators
- Laura L. Staples· Zada L. Giles
- Observations
- 9
- Pages
- 4
- FEI number
- 3002708794
In short: On August 20, 2015, FDA issued a Form 483 with 9 observations to Diabetes Corporation of America in Franklin, Tennessee (FEI 3002708794) after an inspection that ran Aug 11 – Aug 20, 2015. The investigators were Laura L. Staples and Zada L. Giles. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug product containers and closures were not sterilized. and processed to remove pyrogenic properties to assure…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine…
This inspection in context
Laura L. Staples
1 document · 2015
Cites 211.42(c)(10)(iv) (design and construction features) more than any other section. Most of their documents are for sites in Tennessee.
The firmDiabetes Corporation of America history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.94(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diabetes Corporation of America?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Diabetes Corporation of America?
Laura L. Staples and Zada L. Giles are named on this Form 483, for the inspection of Aug 11 – Aug 20, 2015. Each investigator has a profile showing what they cite most.
When was Diabetes Corporation of America inspected by FDA?
The inspection ran Aug 11 – Aug 20, 2015, and the Form 483 is dated August 20, 2015.
How do I get the full Form 483 for Diabetes Corporation of America?
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.