RC Compounding Services, LLC
FDA inspection history in Poland, Ohio, 2013 to 2019
- 3
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2013: one Form 483; 2014: one warning letter; 2015: one Form 483; 2018: one Form 483; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–15Two Form 483s and one warning letter, at Poland, Ohio.
- 2015The longest 483 on file: 9 observations over 5 pages at Poland, Ohio.
- 2018–19One Form 483 and one close-out letter, at Poland, Ohio.
Cited most
Across all RC Compounding Services observations on file
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.67Equipment cleaning and maintenance2
The complete RC Compounding Services file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Poland, Ohio
Three Form 483s, one close-out letter and one warning letter · 2013 to 2019 · 21 observations
Latest: Close-out, Sep 12, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-09-12 | Close-out Close-out letter | Poland, Ohio | — | $99 |
| 2018-02-16 | 483 Form 483 | Poland, Ohio | 6 | $99 |
| 2015-09-14 | 483 Form 483 | Poland, Ohio | 9 | $99 |
| 2014-07-14 | Warning letter Warning letter | Poland, Ohio | — | $99 |
| 2013-02-07 | 483 Form 483 | Poland, Ohio | 6 | $99 |
Investigators on these documents
Dant Culver (1)Janet L. Bowen (1)Jazmine N. Still (1)Joshua S. Hunt (1)Matthew B. Casale (1)
FEI number 3009988995 · most recent document Sep 12, 2019
About RC Compounding Services, LLC
How many FDA Form 483s has RC Compounding Services, LLC received?
FDA Intel has 3 Form 483s on file for RC Compounding Services, LLC; the most recent is dated Feb 16, 2018.
When was RC Compounding Services, LLC last inspected by FDA?
The most recent FDA inspection document on file for RC Compounding Services, LLC is a Form 483 dated Feb 16, 2018, for the site in Poland, Ohio.
What did FDA cite at RC Compounding Services, LLC?
The regulations cited most in the observations on file for RC Compounding Services, LLC are 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.42 (Design and construction features), 6 times; 21 CFR 211.165(a) (Testing and release for distribution), 2 times.
Has RC Compounding Services, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for RC Compounding Services, LLC; the most recent is dated Jul 14, 2014.