RC Compounding Services, LLC
Form 483 issued September 14, 2015 · Poland, Ohio
- Inspection
- Aug 3, 2015 – Aug 6, 2021
- Investigator
- Janet L. Bowen
- Observations
- 9
- Pages
- 5
- FEI number
- 3009988995
In short: On September 14, 2015, FDA issued a Form 483 with 9 observations to RC Compounding Services, LLC in Poland, Ohio (FEI 3009988995) after an inspection that ran Aug 3, 2015 – Aug 6, 2021. The investigator was Janet L. Bowen. 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 7 of 9 observations.
Most cited: 21 CFR 211.42 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Clothing of personnel engaged in the manufacturing of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
This inspection in context
Janet L. Bowen
4 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmRC Compounding Services, LLC history
All 5 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 RC Compounding Services, LLC?
FDA listed 9 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 RC Compounding Services, LLC?
Janet L. Bowen is named on this Form 483, for the inspection of Aug 3, 2015 – Aug 6, 2021. Each investigator has a profile showing what they cite most.
When was RC Compounding Services, LLC inspected by FDA?
The inspection ran Aug 3, 2015 – Aug 6, 2021, and the Form 483 is dated September 14, 2015.
How do I get the full Form 483 for RC Compounding Services, LLC?
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.