PharMEDium Services LLC
FDA inspection history across 2 sites, 2013 to 2017
- 4
- Form 483s
Every document, by year
- Form 483
2013: one Form 483; 2015: one Form 483; 2016: one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–17Four Form 483s, at Edison, New Jersey and Dayton, New Jersey.
- 2017The longest 483 on file: 11 observations over 12 pages at Dayton, New Jersey.
Cited most
Across all PharMEDium Services observations on file
- 21 CFR 211.42Design and construction features8
- 21 CFR 211.160General requirements4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.167(a)Special testing requirements3
The complete PharMEDium Services 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
Edison, New Jersey
Three Form 483s · 2013 to 2016 · 26 observations
Latest: Form 483, May 26, 2016 →Dayton, New Jersey
One Form 483 · 2017 · 11 observations
Latest: Form 483, Dec 13, 2017 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-12-13 | 483 Form 483 | Dayton, New Jersey | 11 | $99 |
| 2016-05-26 | 483 Form 483 | Edison, New Jersey | 9 | $99 |
| 2015-07-13 | 483 Form 483 | Edison, New Jersey | 10 | $99 |
| 2013-02-28 | 483 Form 483 | Edison, New Jersey | 7 | $99 |
Investigators on these documents
Nicholas Violand (2)Barbara J. Wilimczyk-Macri (1)Barbara J. Wiliwtczyk-Macri (1)Adetutu Gidado (1)Mina Ahmadi (1)Russell J. Glapion (1)James A. Liubicich (1)
FEI number 2242985 · most recent document Dec 13, 2017
About PharMEDium Services LLC
How many FDA Form 483s has PharMEDium Services LLC received?
FDA Intel has 4 Form 483s on file for PharMEDium Services LLC; the most recent is dated Dec 13, 2017.
When was PharMEDium Services LLC last inspected by FDA?
The most recent FDA inspection document on file for PharMEDium Services LLC is a Form 483 dated Dec 13, 2017, for the site in Dayton, New Jersey.
What did FDA cite at PharMEDium Services LLC?
The regulations cited most in the observations on file for PharMEDium Services LLC are 21 CFR 211.42 (Design and construction features), 8 times; 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times.