Pharmakon Pharmaceuticals Inc.
Form 483 issued March 13, 2014 · Noblesville, Michigan
- Inspection
- Mar 5 – Mar 13, 2014
- Investigators
- Emily J. Orban· Sarah M. Napier
- Observations
- 11
- Pages
- 9
- FEI number
- 3008213711
In short: On March 13, 2014, FDA issued a Form 483 with 11 observations to Pharmakon Pharmaceuticals Inc. in Noblesville, Michigan (FEI 3008213711) after an inspection that ran Mar 5 – Mar 13, 2014. The investigators were Emily J. Orban and Sarah M. Napier. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 11 observations.
Most cited: 21 CFR 211.42 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 03
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Emily J. Orban
19 documents · 2012–2020
Cites 211.42 (design and construction features) 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmakon Pharmaceuticals Inc.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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.?
Emily J. Orban and Sarah M. Napier are named on this Form 483, for the inspection of Mar 5 – Mar 13, 2014. Each investigator has a profile showing what they cite most.
When was Pharmakon Pharmaceuticals Inc. inspected by FDA?
The inspection ran Mar 5 – Mar 13, 2014, and the Form 483 is dated March 13, 2014.
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.