Pharmakon Pharmaceuticals Inc.
Form 483 issued April 8, 2014 · Noblesville, Indiana
- Inspection
- Apr 2 – Apr 8, 2014
- Investigator
- Meisha R. Waters
- Observations
- 4
- Pages
- 2
- FEI number
- 3008213711
In short: On April 8, 2014, FDA issued a Form 483 with 4 observations to Pharmakon Pharmaceuticals Inc. in Noblesville, Indiana (FEI 3008213711) after an inspection that ran Apr 2 – Apr 8, 2014. The investigator was Meisha R. Waters. Most observations concern packaging & labeling and production.
At a glance
Packaging & labeling and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The results of the examination of the packaged and labeled products were not documented in the…
- 04
Examination of packaging and labeling materials for suitability and correctness before packaging operations is not performed…
This inspection in context
Meisha R. Waters
5 documents · 2011–2020
Cites 118.10 (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Indiana.
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 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmakon Pharmaceuticals Inc.?
FDA listed 4 observations on this Form 483, mostly about packaging & labeling, production and quality system. The opening words of each observation are shown on this page.
Who inspected Pharmakon Pharmaceuticals Inc.?
Meisha R. Waters is named on this Form 483, for the inspection of Apr 2 – Apr 8, 2014. Each investigator has a profile showing what they cite most.
When was Pharmakon Pharmaceuticals Inc. inspected by FDA?
The inspection ran Apr 2 – Apr 8, 2014, and the Form 483 is dated April 8, 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.