PharMEDium Services LLC
FDA inspection history in Sugar Land, Texas, 2007 to 2017
- 5
- Form 483s
Every document, by year
- Form 483
2007: one Form 483; 2010: one Form 483; 2013: one Form 483; 2015: one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2007One Form 483, at Sugar Land, Texas.
- 2010One Form 483, at Sugar Land, Texas.
- 2013–17Three Form 483s, at Sugar Land, Texas.
- 2017The longest 483 on file: 13 observations over 10 pages at Sugar Land, Texas.
Cited most
Across all PharMEDium Services observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.165(a)Testing and release for distribution4
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review2
The complete PharMEDium Services file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Sugar Land, Texas
Five Form 483s · 2007 to 2017 · 39 observations
Latest: Form 483, Dec 22, 2017 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-12-22 | 483 Form 483 | Sugar Land, Texas | 13 | $99 |
| 2015-09-24 | 483 Form 483 | Sugar Land, Texas | 7 | $99 |
| 2013-02-27 | 483 Form 483 | Sugar Land, Texas | 9 | $99 |
| 2010-11-10 | 483 Form 483 | Sugar Land, Texas | 3 | $99 |
| 2007-09-19 | 483 Form 483 | Sugar Land, Texas | 7 | $99 |
Investigators on these documents
Stephen D. Brown (5)Jason R. Caballero (2)Camerson E. Moore (1)Daniel J. Lahar (1)Scott Ballard (1)
FEI number 3000717703 · most recent document Dec 22, 2017
About PharMEDium Services LLC
How many FDA Form 483s has PharMEDium Services LLC received?
FDA Intel has 5 Form 483s on file for PharMEDium Services LLC; the most recent is dated Dec 22, 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 22, 2017, for the site in Sugar Land, Texas.
What did FDA cite at PharMEDium Services LLC?
The regulations cited most in the observations on file for PharMEDium Services LLC are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.165(a) (Testing and release for distribution), 4 times.