Strukmyer Medical
FDA inspection history in Mesquite, Texas, 2024 to 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2024–25One Form 483 and one warning letter, at Mesquite, Texas.
Cited most
Across all Strukmyer Medical observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 2101
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.192Production record review1
The complete Strukmyer Medical file.
All 2 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
Mesquite, Texas
One warning letter and one Form 483 · 2024 to 2025 · 9 observations
Latest: Warning letter, Jan 30, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-30 | Warning letter Warning letter | Mesquite, Texas | — | $99 |
| 2024-08-01 | 483 Form 483 | Mesquite, Texas | 9 | $99 |
Investigators on these documents
FEI number 3000205837 · most recent document Jan 30, 2025
About Strukmyer Medical
How many FDA Form 483s has Strukmyer Medical received?
FDA Intel has 1 Form 483 on file for Strukmyer Medical; the most recent is dated Aug 1, 2024.
When was Strukmyer Medical last inspected by FDA?
The most recent FDA inspection document on file for Strukmyer Medical is a Form 483 dated Aug 1, 2024, for the site in Mesquite, Texas.
What did FDA cite at Strukmyer Medical?
The regulations cited most in the observations on file for Strukmyer Medical are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 210, 1 time; 21 CFR 211.160 (General requirements), 1 time.
Has Strukmyer Medical received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Strukmyer Medical; the most recent is dated Jan 30, 2025.