Pharmakon Compounding Pharmacy Inc.
Form 483 issued May 6, 2016 · Noblesville, Indiana
- Inspection
- Apr 18 – May 6, 2016
- Investigators
- Charles L. Zhou· Constantin Y. Philopoulos
- Observations
- 11
- Pages
- 10
- FEI number
- 3012248018
In short: On May 6, 2016, FDA issued a Form 483 with 11 observations to Pharmakon Compounding Pharmacy Inc. in Noblesville, Indiana (FEI 3012248018) after an inspection that ran Apr 18 – May 6, 2016. The investigators were Charles L. Zhou and Constantin Y. Philopoulos. 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 8 of 11 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Charles L. Zhou
11 documents · 2016–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Michigan.
The firmPharmakon Compounding Pharmacy Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmakon Compounding Pharmacy 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 Compounding Pharmacy Inc.?
Charles L. Zhou and Constantin Y. Philopoulos are named on this Form 483, for the inspection of Apr 18 – May 6, 2016. Each investigator has a profile showing what they cite most.
When was Pharmakon Compounding Pharmacy Inc. inspected by FDA?
The inspection ran Apr 18 – May 6, 2016, and the Form 483 is dated May 6, 2016.
How do I get the full Form 483 for Pharmakon Compounding Pharmacy 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.