Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
10 Jun 2026
21 CFR 111.140(b)(2)
Records - date and signature; review, approval, rejection
Cited by Geneve M Parks, Hassan M Fakhreddine
10 Jun 2026
21 CFR 111.15(b)
Physical plant - clean and sanitary
Cited by Geneve M Parks, Hassan M Fakhreddine
10 Jun 2026
21 CFR 111.205(a)
Master manufacturing record - prepared
Cited by Geneve M Parks, Hassan M Fakhreddine
10 Jun 2026
21 CFR 111.260
Batch record - required information
Cited by Geneve M Parks, Hassan M Fakhreddine
10 Jun 2026
21 CFR 111.455(c)
Hold - mix-up, contamination, deterioration
Cited by Geneve M Parks, Hassan M Fakhreddine
Inspected site
ULUEG, LLCRochester Hills, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.140(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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