Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
23 Dec 2019
21 CFR 111.210(d)
Master manufacturing record - Supplemental Facts
Cited by Felicia M Orlando
23 Dec 2019
21 CFR 111.210(f)
Master manufacturing record theoretical and expected yield
Cited by Felicia M Orlando
23 Dec 2019
21 CFR 111.35(b)(3)
Instruments, controls; calibrate date, reference std, method
Cited by Felicia M Orlando
Inspected site
BLBiotron Laboratories, LLCOgden, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(3) | 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)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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