Diabetes Corporation of America
Form 483 issued June 15, 2017 · Franklin, Tennessee
- Inspection
- Jun 5 – Jun 15, 2017
- Investigator
- Brandon C. Hetnaber
- Observations
- 5
- Pages
- 2
- FEI number
- 3002708794
In short: On June 15, 2017, FDA issued a Form 483 with 5 observations to Diabetes Corporation of America in Franklin, Tennessee (FEI 3002708794) after an inspection that ran Jun 5 – Jun 15, 2017. The investigator was Brandon C. Hetnaber. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Cleaning pads or wipes used in the ISO 5…
- 02
The !SO-classified areas have difficult to clean, particle-generating, or visibly…
- 03
Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with…
- 04
Your firm released drug product in which the strength differs from, or its purity or quality…
This inspection in context
Brandon C. Hetnaber
1 document · 2017
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diabetes Corporation of America?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Diabetes Corporation of America?
Brandon C. Hetnaber is named on this Form 483, for the inspection of Jun 5 – Jun 15, 2017. Each investigator has a profile showing what they cite most.
When was Diabetes Corporation of America inspected by FDA?
The inspection ran Jun 5 – Jun 15, 2017, and the Form 483 is dated June 15, 2017.
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.