Accupack Midwest
Form 483 issued February 27, 2024 · Cincinnati, Ohio
- Inspection
- Feb 22 – Feb 27, 2024
- Investigator
- Wen Ning Chan
- Observations
- 4
- Pages
- 4
- FEI number
- 1000122754
In short: On February 27, 2024, FDA issued a Form 483 with 4 observations to Accupack Midwest in Cincinnati, Ohio (FEI 1000122754) after an inspection that ran Feb 22 – Feb 27, 2024. The investigator was Wen Ning Chan. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are lacking which describe in sufficient detail the sampling, testing, approval…
- 02
Routine inspection and checking of automatic and electronic equipment is not performed according to a written…
- 03
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 04
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Wen Ning Chan
10 documents · 2021–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ohio.
The firmAccupack Midwest history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.80(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Accupack Midwest?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and production. The opening words of each observation are shown on this page.
Who inspected Accupack Midwest?
Wen Ning Chan is named on this Form 483, for the inspection of Feb 22 – Feb 27, 2024. Each investigator has a profile showing what they cite most.
When was Accupack Midwest inspected by FDA?
The inspection ran Feb 22 – Feb 27, 2024, and the Form 483 is dated February 27, 2024.
How do I get the full Form 483 for Accupack Midwest?
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.