Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-12-18.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Dec 2017 – 18 Dec 2017 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Dec 2017
21 CFR 211.166(a)
Lack of written stability program
Cited by Bryan A Galvez, Christopher D Washington
18 Dec 2017
21 CFR 211.198(a)
Procedures to be written and followed
Cited by Bryan A Galvez, Christopher D Washington
18 Dec 2017
21 CFR 211.22(a)
Lack of quality control unit
Cited by Bryan A Galvez, Christopher D Washington
18 Dec 2017
21 CFR 211.84(a)
Components withheld from use pending release
Cited by Bryan A Galvez, Christopher D Washington
18 Dec 2017
21 CFR 211.87
Retest of approved components/containers/closures
Cited by Bryan A Galvez, Christopher D Washington
Investigators
FDA investigators tied to this site in the record.
Bryan A Galvez1 insp.
Christopher D Washington1 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 | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind bB BIOCHEM LABORATORIES INC.'s 1 Form 483
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