RC Outsourcing LLC
Form 483 issued March 31, 2017 · Lowellville, Ohio
- Inspection
- Mar 27 – Mar 31, 2017
- Investigators
- Jazmine N. Still· Matthew B. Casale
- Observations
- 9
- Pages
- 5
- FEI number
- 3011967886
In short: On March 31, 2017, FDA issued a Form 483 with 9 observations to RC Outsourcing LLC in Lowellville, Ohio (FEI 3011967886) after an inspection that ran Mar 27 – Mar 31, 2017. The investigators were Jazmine N. Still and Matthew B. Casale. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and facilities & equipment account for 6 of 9 observations.
Most cited: 21 CFR 211.167(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
EMPLOYEE($) SIGNATURE DATE lSSUEO 3111/2017 Aseptic processing areas are deficient regarding the system for cleaning and…
- 03
Clothing of personnel engaged in the manufacturing, processing and packing of drug products is not appropriate…
- 04
Each batch of drug product purporting to be pyrogen-free is not laboratory tested to determine…
This inspection in context
Jazmine N. Still
16 documents · 2017–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmRC Outsourcing LLC history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.167(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RC Outsourcing LLC?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, facilities & equipment 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 RC Outsourcing LLC?
Jazmine N. Still and Matthew B. Casale are named on this Form 483, for the inspection of Mar 27 – Mar 31, 2017. Each investigator has a profile showing what they cite most.
When was RC Outsourcing LLC inspected by FDA?
The inspection ran Mar 27 – Mar 31, 2017, and the Form 483 is dated March 31, 2017.
How do I get the full Form 483 for RC Outsourcing 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.