Techni Med, Inc. dba The Compounder
FDA inspection history in Aurora, Illinois, 2015 to 2020
- 3
- Form 483s
- 2
- Close-outs
Every document, by year
- Close-out
- Form 483
2015: one Form 483; 2016: one close-out letter; 2018: one Form 483; 2019: one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–20Three Form 483s and two close-out letters, at Aurora, Illinois.
- 2015The longest 483 on file: 10 observations over 6 pages at Aurora, Illinois.
Cited most
Across all Techni Med, Inc. dba The Compounder observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.42Design and construction features3
- FDCA 501(a)(2)(A)Insanitary conditions3
- 21 CFR 211.166Stability testing2
The complete Techni Med, Inc. dba The Compounder file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Aurora, Illinois
Three Form 483s and two close-out letters · 2015 to 2020 · 21 observations
Latest: Close-out, May 5, 2020 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-05-05 | Close-out Close-out letter | Aurora, Illinois | — | $99 |
| 2019-10-10 | 483 Form 483 | Aurora, Illinois | 5 | $99 |
| 2018-01-26 | 483 Form 483 | Aurora, Illinois | 6 | $99 |
| 2016-07-29 | Close-out Close-out letter | Aurora, Illinois | — | $99 |
| 2015-08-05 | 483 Form 483 | Aurora, Illinois | 10 | $99 |
Investigators on these documents
Bryan L. McGuckin (1)Christina A. Miller (1)Emilie Kahn (1)James K. Ireland (1)
FEI number 3004504906 · most recent document May 5, 2020
About Techni Med, Inc. dba The Compounder
How many FDA Form 483s has Techni Med, Inc. dba The Compounder received?
FDA Intel has 3 Form 483s on file for Techni Med, Inc. dba The Compounder; the most recent is dated Oct 10, 2019.
When was Techni Med, Inc. dba The Compounder last inspected by FDA?
The most recent FDA inspection document on file for Techni Med, Inc. dba The Compounder is a Form 483 dated Oct 10, 2019, for the site in Aurora, Illinois.
What did FDA cite at Techni Med, Inc. dba The Compounder?
The regulations cited most in the observations on file for Techni Med, Inc. dba The Compounder are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.165 (Testing and release for distribution), 3 times; 21 CFR 211.42 (Design and construction features), 3 times.