Strukmyer Medical
Form 483 issued August 1, 2024 · Mesquite, Texas
- Investigator
- Jamillah Selby
- Observations
- 9
- Pages
- 12
- FEI number
- 3000205837
In short: On August 1, 2024, FDA issued a Form 483 with 9 observations to Strukmyer Medical in Mesquite, Texas (FEI 3000205837). The investigator was Jamillah Selby. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.110 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 0421 CFR 210
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
This inspection in context
Jamillah Selby
7 documents · 2013–2024
Cites 211.42(c)(10)(iv) (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmStrukmyer Medical history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Strukmyer Medical?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Strukmyer Medical?
Jamillah Selby is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Strukmyer Medical inspected by FDA?
This Form 483 is dated August 1, 2024.
How do I get the full Form 483 for Strukmyer Medical?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.