Ranier's Compounding Laboratory
FDA inspection history across 2 sites, 2016 to 2024
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one Form 483; 2017: one warning letter; 2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19Two Form 483s and one warning letter, at Jeannette, Pennsylvania.
- 2019The longest 483 on file: 9 observations over 5 pages at Jeannette, Pennsylvania.
- 2024One Form 483, at J eannette, Pennsylvania.
Cited most
Across all Ranier's Compounding Laboratory observations on file
- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.28Personnel responsibilities2
- FDCA 501(a)(2)(A)Insanitary conditions2
- 21 CFR 211.166(a)Stability testing1
The complete Ranier's Compounding Laboratory file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Jeannette, Pennsylvania
Two Form 483s and one warning letter · 2016 to 2019 · 16 observations
Latest: Form 483, Feb 6, 2019 →J eannette, Pennsylvania
One Form 483 · 2024 · 2 observations
Latest: Form 483, Feb 13, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-13 | 483 Form 483 | J eannette, Pennsylvania | 2 | $99 |
| 2019-02-06 | 483 Form 483 | Jeannette, Pennsylvania | 9 | $99 |
| 2017-03-28 | Warning letter Warning letter | Jeannette, Pennsylvania | — | $99 |
| 2016-04-22 | 483 Form 483 | Jeannette, Pennsylvania | 7 | $99 |
Investigators on these documents
FEI number 3012124170 · most recent document Feb 13, 2024
About Ranier's Compounding Laboratory
How many FDA Form 483s has Ranier's Compounding Laboratory received?
FDA Intel has 3 Form 483s on file for Ranier's Compounding Laboratory; the most recent is dated Feb 13, 2024.
When was Ranier's Compounding Laboratory last inspected by FDA?
The most recent FDA inspection document on file for Ranier's Compounding Laboratory is a Form 483 dated Feb 13, 2024, for the site in J eannette, Pennsylvania.
What did FDA cite at Ranier's Compounding Laboratory?
The regulations cited most in the observations on file for Ranier's Compounding Laboratory are 21 CFR 211.113 (Control of microbiological contamination), 7 times; 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.28 (Personnel responsibilities), 2 times.
Has Ranier's Compounding Laboratory received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Ranier's Compounding Laboratory; the most recent is dated Mar 28, 2017.