Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-09-24.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Sep 2019 – 24 Sep 2019 | Medical Devices & Rad Health | Clean | |
| 30 Jul 2015 – 7 Aug 2015 | Medical Devices & Rad Health | Clean | |
| 26 Jul 2011 | Not recorded | 483 | View 483 → |
| 12 Feb 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jul 2011
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Yvette M Lacour-Davis, Laverne Kimble
26 Jul 2011
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Yvette M Lacour-Davis, Laverne Kimble
26 Jul 2011
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Yvette M Lacour-Davis, Laverne Kimble
26 Jul 2011
21 CFR 820.150
Lack of or inadequate procedures for storage.
Cited by Yvette M Lacour-Davis, Laverne Kimble
Investigators
FDA investigators tied to this site in the record.
Janet Pulver1 insp.
Tuan A Nguyen1 insp.
Juanita Banuelos1 insp.
Yvette M Lacour-Davis1 insp.
Laverne Kimble1 insp.
Michael Araneta1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biocell Laboratories Inc's 1 Form 483
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