Pharmakon Pharmaceuticals Inc.
Form 483 issued March 16, 2016 · Noblesville, Indiana
- Inspection
- Feb 18 – Mar 16, 2016
- Investigators
- Emilie Kahn· Emily J. Orban· Gary C. Pecic
- Observations
- 14
- Pages
- 17
- FEI number
- 3008213711
In short: On March 16, 2016, FDA issued a Form 483 with 14 observations to Pharmakon Pharmaceuticals Inc. in Noblesville, Indiana (FEI 3008213711) after an inspection that ran Feb 18 – Mar 16, 2016. The investigators were Emilie Kahn, Emily J. Orban, Gary C. Pecic and Lisa T. Michel. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Procedmes designed to prevent microbiological contamination of dmg products pmporting to be sterile are not established…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
The firmPharmakon Pharmaceuticals Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmakon Pharmaceuticals Inc.?
FDA listed 14 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. 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 Pharmakon Pharmaceuticals Inc.?
Emilie Kahn, Emily J. Orban, Gary C. Pecic and Lisa T. Michel are named on this Form 483, for the inspection of Feb 18 – Mar 16, 2016. Each investigator has a profile showing what they cite most.
When was Pharmakon Pharmaceuticals Inc. inspected by FDA?
The inspection ran Feb 18 – Mar 16, 2016, and the Form 483 is dated March 16, 2016.
How do I get the full Form 483 for Pharmakon Pharmaceuticals Inc.?
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.