Overview
- 17 public-safe observations are available for this inspection.
- 17 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 111.105(i)
Quality control - required operations
Cited by Geneve M Parks, Hassan M Fakhreddine
10 Jun 2026
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Geneve M Parks, Hassan M Fakhreddine
10 Jun 2026
21 CFR 111.123(a)(8)
Quality control - finished batch, distribution
Cited by Geneve M Parks, Hassan M Fakhreddine
10 Jun 2026
21 CFR 111.12(b)
Personnel - quality control operations; responsibilities
Cited by Geneve M Parks, Hassan M Fakhreddine
10 Jun 2026
21 CFR 111.140(b)(2)
Records - date and signature; review, approval, rejection
Cited by Geneve M Parks, Hassan M Fakhreddine
Inspected site
LBLXR BiotechRochester Hills, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210 | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | 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)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 17 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