FDA Intel

Techni Med, Inc. dba The Compounder

Form 483 issued January 26, 2018 · Aurora, Illinois

Inspection
Jan 8 – Jan 26, 2018
Investigators
Bryan L. McGuckin· Emilie Kahn
Observations
6
Pages
8
FEI number
3004504906

In short: On January 26, 2018, FDA issued a Form 483 with 6 observations to Techni Med, Inc. dba The Compounder in Aurora, Illinois (FEI 3004504906) after an inspection that ran Jan 8 – Jan 26, 2018. The investigators were Bryan L. McGuckin and Emilie Kahn. Most observations concern production and laboratory controls.

At a glance

Production and laboratory controls account for 5 of 6 observations.

Production3
Laboratory controls2
Other1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…

  2. 02
    21 CFR 211.165(a)

    Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…

  3. 03
    21 CFR 211.166(a)

    Results of stability testing are not used…

  4. 04
    21 CFR 211.100(a)

    There are no written procedures for production and process controls designed to assure that the drug…

2 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Bryan L. McGuckin

30 documents · 2017–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.

The firm

Techni Med, Inc. dba The Compounder history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Techni Med, Inc. dba The Compounder?

FDA listed 6 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.

Who inspected Techni Med, Inc. dba The Compounder?

Bryan L. McGuckin and Emilie Kahn are named on this Form 483, for the inspection of Jan 8 – Jan 26, 2018. Each investigator has a profile showing what they cite most.

When was Techni Med, Inc. dba The Compounder inspected by FDA?

The inspection ran Jan 8 – Jan 26, 2018, and the Form 483 is dated January 26, 2018.

How do I get the full Form 483 for Techni Med, Inc. dba The Compounder?

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.

$99Get it free