Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-01-16.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jan 2020 – 16 Jan 2020 | Human Drugs | 483 | On file |
| 5 Aug 2019 – 14 Aug 2019 | Human Drugs | 483 | View 483 → |
| 5 Jun 2017 – 15 Jun 2017 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Aug 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Simone E Pitts, Peng Zhou, Jonathan G Gayechuway
14 Aug 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Simone E Pitts, Peng Zhou, Jonathan G Gayechuway
14 Aug 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Simone E Pitts, Peng Zhou, Jonathan G Gayechuway
14 Aug 2019
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Simone E Pitts, Peng Zhou, Jonathan G Gayechuway
14 Aug 2019
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Simone E Pitts, Peng Zhou, Jonathan G Gayechuway
Investigators
FDA investigators tied to this site in the record.
Michele Perry-Williams1 insp.
Simone E Pitts1 insp.
Peng Zhou1 insp.
Jonathan G Gayechuway1 insp.
Kellia N Hicks1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind NorthStar Medical Radioisotopes, LLC's 3 Form 483s
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