Higley Industries, Inc.
Form 483 issued September 21, 2023 · Dyersville, Iowa
- Investigator
- Torrey M. Ward
- Observations
- 6
- Pages
- 5
- FEI number
- 3002984417
In short: On September 21, 2023, FDA issued a Form 483 with 6 observations to Higley Industries, Inc. in Dyersville, Iowa (FEI 3002984417). The investigator was Torrey M. Ward. Most observations concern production and materials.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Master production and control records lack complete manufacturing and control instructions and…
- 02
Representative samples are not taken of each shipment of each lot of components, drug product containers…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 04
Routine calibration and inspection of mechanical equipment is not performed according to a written program designed…
This inspection in context
Torrey M. Ward
13 documents · 2021–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Iowa.
The firmHigley Industries, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.186(b)(9)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Higley Industries, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Higley Industries, Inc.?
Torrey M. Ward is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Higley Industries, Inc. inspected by FDA?
This Form 483 is dated September 21, 2023.
How do I get the full Form 483 for Higley Industries, Inc.?
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.