Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Mar 2026
21 CFR 211.105(a)
Identification of containers, lines, equipment
Cited by Amatul H Marium, WenNing Chan
5 Mar 2026
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Amatul H Marium, WenNing Chan
5 Mar 2026
21 CFR 211.68(b)
Computer control of master formula records
Cited by Amatul H Marium, WenNing Chan
Inspected site
AIAccra-Pac, Inc.Elkhart, United States
Inspection team
WCWenNing Chan
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere