RC Compounding Services, LLC
Form 483 issued February 16, 2018 · Poland, Ohio
- Inspection
- Feb 12 – Feb 16, 2018
- Investigators
- Jazmine N. Still· Matthew B. Casale
- Observations
- 6
- Pages
- 4
- FEI number
- 3009988995
In short: On February 16, 2018, FDA issued a Form 483 with 6 observations to RC Compounding Services, LLC in Poland, Ohio (FEI 3009988995) after an inspection that ran Feb 12 – Feb 16, 2018. The investigators were Jazmine N. Still and Matthew B. Casale. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 6 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (4×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel placed equipment/supplies in an area that blocked the movement of first pass air around an…
- 02
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
- 03
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…
- 04
Non-sterilized and Non-depyrogenated equipment was used…
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 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RC Compounding Services, LLC?
FDA listed 6 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 RC Compounding Services, LLC?
Jazmine N. Still and Matthew B. Casale are named on this Form 483, for the inspection of Feb 12 – Feb 16, 2018. Each investigator has a profile showing what they cite most.
When was RC Compounding Services, LLC inspected by FDA?
The inspection ran Feb 12 – Feb 16, 2018, and the Form 483 is dated February 16, 2018.
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.