Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-09-11.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Sep 2024 – 11 Sep 2024 | Foods & Cosmetics | Clean | |
| 18 Dec 2019 – 23 Dec 2019 | Foods & Cosmetics | 483 | View 483 → |
| 24 Sep 2014 | Foods & Cosmetics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| 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 site report
Get the verbatim findings behind Biotron Laboratories, LLC's 1 Form 483
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat