Essential Pharmacy Compounding LLC
FDA inspection history in Omaha, Nebraska, 2015 to 2019
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2017: one Form 483; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Two Form 483s, one warning letter and one close-out letter, at Omaha, Nebraska.
- 2015The longest 483 on file: 12 observations over 7 pages at Omaha, Nebraska.
Cited most
Across all Essential Pharmacy Compounding observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.192Production record review1
The complete Essential Pharmacy Compounding 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
Omaha, Nebraska
Two Form 483s, one close-out letter and one warning letter · 2015 to 2019 · 15 observations
Latest: Close-out, Jul 11, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-07-11 | Close-out Close-out letter | Omaha, Nebraska | — | $99 |
| 2017-07-27 | 483 Form 483 | Omaha, Nebraska | 3 | $99 |
| 2016-03-10 | Warning letter Warning letter | Omaha, Nebraska | — | $99 |
| 2015-07-23 | 483 Form 483 | Omaha, Nebraska | 12 | $99 |
Investigators on these documents
Eric M. Mueller (1)Jenny Agila Sefen (1)Joseph R. Lambert (1)Kellia N. Hicks (1)
FEI number 3003718003 · most recent document Jul 11, 2019
About Essential Pharmacy Compounding LLC
How many FDA Form 483s has Essential Pharmacy Compounding LLC received?
FDA Intel has 2 Form 483s on file for Essential Pharmacy Compounding LLC; the most recent is dated Jul 27, 2017.
When was Essential Pharmacy Compounding LLC last inspected by FDA?
The most recent FDA inspection document on file for Essential Pharmacy Compounding LLC is a Form 483 dated Jul 27, 2017, for the site in Omaha, Nebraska.
What did FDA cite at Essential Pharmacy Compounding LLC?
The regulations cited most in the observations on file for Essential Pharmacy Compounding LLC are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.165 (Testing and release for distribution), 1 time.
Has Essential Pharmacy Compounding LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Essential Pharmacy Compounding LLC; the most recent is dated Mar 10, 2016.