Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy
Form 483 issued August 10, 2018 · Peoria, Illinois
- Inspection
- Jul 30 – Aug 10, 2018
- Investigator
- Bei Y. He
- Observations
- 5
- Pages
- 4
- FEI number
- 3006572203
In short: On August 10, 2018, FDA issued a Form 483 with 5 observations to Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy in Peoria, Illinois (FEI 3006572203) after an inspection that ran Jul 30 – Aug 10, 2018. The investigator was Bei Y. He. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your facility was designed and/or operated in a way that pennits…
- 02
Non-sterile bulk solutions are held for an extended period with no documentation to…
- 03
Your firm prepares multi-dose sterile drug products with an extended beyond…
- 04
Disinfecting agents and cleaning pads used in the ISO 5 classified aseptic processing…
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 firmCentral Illinois Compounding, Inc. dba Preckshot Professional Pharmacy history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy?
Bei Y. He is named on this Form 483, for the inspection of Jul 30 – Aug 10, 2018. Each investigator has a profile showing what they cite most.
When was Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy inspected by FDA?
The inspection ran Jul 30 – Aug 10, 2018, and the Form 483 is dated August 10, 2018.
How do I get the full Form 483 for Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy?
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.