Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-03-20.
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 |
|---|---|---|---|
| 16 Mar 2020 – 20 Mar 2020 | Human Drugs | 483 | View 483 → |
| 5 Aug 2013 – 30 Aug 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Mar 2020
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Nayan J Patel, Walden H Lee
Investigators
FDA investigators tied to this site in the record.
Nayan J Patel1 insp.
Walden H Lee1 insp.
Zachery L Miller1 insp.
Marie B Buen-Bigornia1 insp.
Andrea S Heise1 insp.
Kimberley A Hoefen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | 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 Front Range Laboratories, Inc.'s 2 Form 483s
Source PDFs 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