Accra-Pac, Inc.
Form 483 issued September 2, 2022 · Elkhart, Indiana
- Inspection
- Aug 23 – Sep 2, 2022
- Observations
- 5
- Pages
- 7
- FEI number
- 1818911
In short: On September 2, 2022, FDA issued a Form 483 with 5 observations to Accra-Pac, Inc. in Elkhart, Indiana (FEI 1818911) after an inspection that ran Aug 23 – Sep 2, 2022. Most observations concern quality system and laboratory controls.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
The responsibilities and procedures applicable to the quality unit are not in…
- 04
The number of containers to be sampled is not…
This inspection in context
Questions about this 483
What did FDA find at Accra-Pac, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and materials. The opening words of each observation are shown on this page.
When was Accra-Pac, Inc. inspected by FDA?
The inspection ran Aug 23 – Sep 2, 2022, and the Form 483 is dated September 2, 2022.
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.