Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-03-15.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2024 – 15 Mar 2024 | Human Drugs | Clean | |
| 7 Dec 2023 | Foods & Cosmetics | Clean | |
| 14 Sep 2016 – 15 Sep 2016 | Human Drugs | Clean | |
| 26 Oct 2011 | Not recorded | Clean | |
| 30 Nov 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Anastasia M Shields1 insp.
Adena S Yau1 insp.
Evan Tong1 insp.
Kyle D Covill1 insp.
Gillian B Nardelli1 insp.
Lisa B Orr1 insp.
Gayle S Lawson1 insp.
Matthew R Noonan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Northtec Keystone'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