Pharmakon Long Term Care Pharmacy Inc.
Form 483 issued May 11, 2016 · Noblesville, Indiana
- Inspection
- Apr 18 – May 11, 2016
- Investigators
- Bei Y. He· Emily J. Orban· Robert M. Barbosa
- Observations
- 8
- Pages
- 6
- FEI number
- 3011756326
In short: On May 11, 2016, FDA issued a Form 483 with 8 observations to Pharmakon Long Term Care Pharmacy Inc. in Noblesville, Indiana (FEI 3011756326) after an inspection that ran Apr 18 – May 11, 2016. The investigators were Bei Y. He, Emily J. Orban and Robert M. Barbosa. 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 6 of 8 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Clothing ofpersonnel engaged in the processing of drug products is not appropriate for…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Bei Y. He
14 documents · 2016–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
The firmPharmakon Long Term Care Pharmacy Inc. history
The site's inspection history, in date order.
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 Long Term Care Pharmacy Inc.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production 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 Long Term Care Pharmacy Inc.?
Bei Y. He, Emily J. Orban and Robert M. Barbosa are named on this Form 483, for the inspection of Apr 18 – May 11, 2016. Each investigator has a profile showing what they cite most.
When was Pharmakon Long Term Care Pharmacy Inc. inspected by FDA?
The inspection ran Apr 18 – May 11, 2016, and the Form 483 is dated May 11, 2016.
How do I get the full Form 483 for Pharmakon Long Term Care 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.