Diabetes Corporation of America
FDA inspection history in Franklin, Tennessee, 2015 to 2017
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Two Form 483s and one warning letter, at Franklin, Tennessee.
- 2015The longest 483 on file: 9 observations over 4 pages at Franklin, Tennessee.
Cited most
Across all Diabetes Corporation of America observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.167(a)Special testing requirements1
The complete Diabetes Corporation of America file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Franklin, Tennessee
Two Form 483s and one warning letter · 2015 to 2017 · 14 observations
Latest: Form 483, Jun 15, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-06-15 | 483 Form 483 | Franklin, Tennessee | 5 | $99 |
| 2016-06-03 | Warning letter Warning letter | Franklin, Tennessee | — | $99 |
| 2015-08-20 | 483 Form 483 | Franklin, Tennessee | 9 | $99 |
Investigators on these documents
Brandon C. Hetnaber (1)Laura L. Staples (1)Zada L. Giles (1)
FEI number 3002708794 · most recent document Jun 15, 2017
About Diabetes Corporation of America
How many FDA Form 483s has Diabetes Corporation of America received?
FDA Intel has 2 Form 483s on file for Diabetes Corporation of America; the most recent is dated Jun 15, 2017.
When was Diabetes Corporation of America last inspected by FDA?
The most recent FDA inspection document on file for Diabetes Corporation of America is a Form 483 dated Jun 15, 2017, for the site in Franklin, Tennessee.
What did FDA cite at Diabetes Corporation of America?
The regulations cited most in the observations on file for Diabetes Corporation of America are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.111 (Time limitations on production), 1 time.
Has Diabetes Corporation of America received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Diabetes Corporation of America; the most recent is dated Jun 3, 2016.