RC Outsourcing LLC
FDA inspection history across 2 sites, 2016 to 2026
- 7
- Form 483s
- 2
- Warning letters
Every document, by year
- Warning letter
- Form 483
2016: one amended 483 and one Form 483; 2017: one warning letter and one Form 483; 2019: one Form 483; 2022: one Form 483; 2024: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19Three Form 483s, one amended 483 and one warning letter, at Lowellville, Ohio and Ohio.
- 2022–26Three Form 483s and one warning letter, at Lowellville, Ohio.
- 2022The longest 483 on file: 10 observations over 10 pages at Lowellville, Ohio.
Cited most
Across all RC Outsourcing observations on file
- 21 CFR 211.42Design and construction features12
- 21 CFR 211.192Production record review7
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.167(a)Special testing requirements4
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment4
The complete RC Outsourcing file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Lowellville, Ohio
Five Form 483s, two warning letters and one amended 483 · 2016 to 2026 · 51 observations
Latest: Warning letter, Mar 20, 2026 →Ohio
One Form 483 · 2016 · 8 observations
Latest: Form 483, Feb 9, 2016 →
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-20 | Warning letter Warning letter | Lowellville, Ohio | — | $99 |
| 2025-08-28 | 483 Form 483 | Lowellville, Ohio | 8 | $99 |
| 2024-09-27 | 483 Form 483 | Lowellville, Ohio | 8 | $99 |
| 2022-09-23 | 483 Form 483 | Lowellville, Ohio | 10 | $99 |
| 2019-02-08 | 483 Form 483 | Lowellville, Ohio | 8 | $99 |
| 2017-11-28 | Warning letter Warning letter | Lowellville, Ohio | — | $99 |
| 2017-03-31 | 483 Form 483 | Lowellville, Ohio | 9 | $99 |
| 2016-02-09 | Amended 483 Amended 483 | Lowellville, Ohio | 8 | $99 |
| 2016-02-09 | 483 Form 483 | Ohio | 8 | $99 |
Investigators on these documents
Joshua P. Wireman (2)Margaret M. Ames (1)Jazmine N. Still (1)Robert M. Barbosa (1)Taichun Qin (1)Ucheabuchi C. Chudi-Nwankwor (1)Matthew B. Casale (1)
FEI number 3011967886 · most recent document Mar 20, 2026
About RC Outsourcing LLC
How many FDA Form 483s has RC Outsourcing LLC received?
FDA Intel has 7 Form 483s on file for RC Outsourcing LLC; the most recent is dated Aug 28, 2025.
When was RC Outsourcing LLC last inspected by FDA?
The most recent FDA inspection document on file for RC Outsourcing LLC is a Form 483 dated Aug 28, 2025, for the site in Lowellville, Ohio.
What did FDA cite at RC Outsourcing LLC?
The regulations cited most in the observations on file for RC Outsourcing LLC are 21 CFR 211.42 (Design and construction features), 12 times; 21 CFR 211.192 (Production record review), 7 times; 21 CFR 211.113 (Control of microbiological contamination), 6 times.
Has RC Outsourcing LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for RC Outsourcing LLC; the most recent is dated Mar 20, 2026.