Overview
- 17 public-safe observations are available for this inspection.
- 16 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.
12 Mar 2025
21 CFR 111.105(a)
Quality control - processes, specifications, written procedures
Cited by Geneve M Parks, Courtney E Hillier
12 Mar 2025
21 CFR 111.120(e)
Quality control operations - quarantine
Cited by Geneve M Parks, Courtney E Hillier
12 Mar 2025
21 CFR 111.12(b)
Personnel - quality control operations; identified
Cited by Geneve M Parks, Courtney E Hillier
12 Mar 2025
21 CFR 111.155(d)(1)
Components - identify lot received
Cited by Geneve M Parks, Courtney E Hillier
12 Mar 2025
21 CFR 111.210
Master manufacturing record - record requirements
Cited by Geneve M Parks, Courtney E Hillier
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 111.75(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.120(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.325(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | 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(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(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.77(b) | 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