Accra-Pac, Inc.
Form 483 issued March 5, 2026 · Elkhart, Indiana
- Inspection
- Feb 26 – Mar 5, 2026
- Investigators
- Amatul H. Marium· Wenning Chan
- Observations
- 5
- Pages
- 5
- FEI number
- 1818911
In short: On March 5, 2026, FDA issued a Form 483 with 5 observations to Accra-Pac, Inc. in Elkhart, Indiana (FEI 1818911) after an inspection that ran Feb 26 – Mar 5, 2026. The investigators were Amatul H. Marium and Wenning Chan. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Your film failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Records are not kept for…
- 04
Written procedures are not followed for…
This inspection in context
Amatul H. Marium
8 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Accra-Pac, Inc.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Accra-Pac, Inc.?
Amatul H. Marium and Wenning Chan are named on this Form 483, for the inspection of Feb 26 – Mar 5, 2026. Each investigator has a profile showing what they cite most.
When was Accra-Pac, Inc. inspected by FDA?
The inspection ran Feb 26 – Mar 5, 2026, and the Form 483 is dated March 5, 2026.
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.