Farmakeio Outsourcing LLC
FDA inspection history in Southlake, Texas, 2019 to 2025
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2019: one Form 483; 2021: one warning letter; 2022: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–22Two Form 483s and one warning letter, at Southlake, Texas.
- 2022The longest 483 on file: 7 observations over 5 pages at Southlake, Texas.
- 2025One Form 483, at Southlake, Texas.
Cited most
Across all Farmakeio Outsourcing observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.42Design and construction features2
- FDCA 503B(a)(10)2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.137(a)Expiration dating1
The complete Farmakeio Outsourcing 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
Southlake, Texas
Three Form 483s and one warning letter · 2019 to 2025 · 15 observations
Latest: Form 483, Sep 5, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-05 | 483 Form 483 | Southlake, Texas | 5 | $99 |
| 2022-06-10 | 483 Form 483 | Southlake, Texas | 7 | $99 |
| 2021-07-29 | Warning letter Warning letter | Southlake, Texas | — | $99 |
| 2019-10-30 | 483 Form 483 | Southlake, Texas | 3 | $99 |
Investigators on these documents
Camerson E. Moore (1)Francis Guidry (1)Patty P. Kaewussdangkul (1)Steven A. Brettler (1)
FEI number 3014982757 · most recent document Sep 5, 2025
About Farmakeio Outsourcing LLC
How many FDA Form 483s has Farmakeio Outsourcing LLC received?
FDA Intel has 3 Form 483s on file for Farmakeio Outsourcing LLC; the most recent is dated Sep 5, 2025.
When was Farmakeio Outsourcing LLC last inspected by FDA?
The most recent FDA inspection document on file for Farmakeio Outsourcing LLC is a Form 483 dated Sep 5, 2025, for the site in Southlake, Texas.
What did FDA cite at Farmakeio Outsourcing LLC?
The regulations cited most in the observations on file for Farmakeio Outsourcing LLC are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.42 (Design and construction features), 2 times; FDCA 503B(a)(10), 2 times.
Has Farmakeio Outsourcing LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Farmakeio Outsourcing LLC; the most recent is dated Jul 29, 2021.