Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-04-26.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Apr 2013 – 26 Apr 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Feb 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Feb 2010
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Emir Galevi, Brenda P King
23 Feb 2010
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Emir Galevi, Brenda P King
23 Feb 2010
21 CFR 820.90(a)
Specific non-conforming product procedures
Cited by Emir Galevi, Brenda P King
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 1002.11 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1002.13 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biolitec, Inc.'s 2 Form 483s
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