Accra-Pac, Inc.
Form 483 issued November 5, 2021 · Elkhart, Indiana
- Inspection
- Nov 2 – Nov 5, 2021
- Investigator
- Suyang Qin
- Observations
- 3
- Pages
- 8
- FEI number
- 1818911
In short: On November 5, 2021, FDA issued a Form 483 with 3 observations to Accra-Pac, Inc. in Elkhart, Indiana (FEI 1818911) after an inspection that ran Nov 2 – Nov 5, 2021. The investigator was Suyang Qin. Most observations concern production & process controls and cAPA.
At a glance
2 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
When test/measurement equipment was found to not meet accuracy and precision limits, inadequate action was taken…
- 03
Procedures for corrective and preventive action have…
This inspection in context
Suyang Qin
9 documents · 2015–2026
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Indiana.
The firmAccra-Pac, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Accra-Pac, Inc.?
FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Accra-Pac, Inc.?
Suyang Qin is named on this Form 483, for the inspection of Nov 2 – Nov 5, 2021. Each investigator has a profile showing what they cite most.
When was Accra-Pac, Inc. inspected by FDA?
The inspection ran Nov 2 – Nov 5, 2021, and the Form 483 is dated November 5, 2021.
How do I get the full Form 483 for Accra-Pac, 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.