Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-24.
At a glance
Inspections
6
Form 483s
6
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jul 2025 – 24 Jul 2025 | Human Drugs | 483 | View 483 → |
| 21 Mar 2019 – 26 Mar 2019 | Human Drugs | 483 | View 483 → |
| 13 May 2014 – 10 Jun 2014 | Human Drugs | 483 | View 483 → |
| 14 May 2012 | Not recorded | 483 | View 483 → |
| 15 Jun 2011 | Not recorded | WL | View 483 → |
| 9 Jul 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jul 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Janet A Rajan, Michael O Idowu
26 Mar 2019
21 CFR 211.160(b)(4)
Instruments, apparatus, et. al. not meeting specs
Cited by Saleem A Akhtar
14 May 2012
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Lauren L Vajo, Lisa M Bellows
14 May 2012
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Lauren L Vajo, Lisa M Bellows
Investigators
FDA investigators tied to this site in the record.
Lauren L Vajo2 insp.
Lisa M Bellows2 insp.
Janet A Rajan1 insp.
Michael O Idowu1 insp.
Saleem A Akhtar1 insp.
Jose M Cayuela1 insp.
Barbara J Wilimczyk-Macri1 insp.
Helen Verdel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biochem Laboratory, Inc.'s 6 Form 483s
Source PDFs, verbatim observations, and 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