Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy
Form 483 issued September 19, 2017 · Peoria, Illinois
- Inspection
- Jun 12 – Sep 19, 2017
- Investigators
- Robert J. Ham· Tiara N. Brown-Crosen
- Observations
- 5
- Pages
- 3
- FEI number
- 3006572203
In short: On September 19, 2017, 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 Jun 12 – Sep 19, 2017. The investigators were Robert J. Ham and Tiara N. Brown-Crosen. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm released drug product in which the strength differs from, or its purity or quality…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
This inspection in context
Robert J. Ham
32 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
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 211.42
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 facilities & equipment, materials and production. 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 Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy?
Robert J. Ham and Tiara N. Brown-Crosen are named on this Form 483, for the inspection of Jun 12 – Sep 19, 2017. 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 Jun 12 – Sep 19, 2017, and the Form 483 is dated September 19, 2017.
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.