Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-08.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Jul 2025 – 8 Aug 2025 | Human Drugs | 483 | View 483 → |
| 27 Sep 2022 – 4 Oct 2022 | Human Drugs | 483 | View 483 → |
| 20 Mar 2017 – 24 Mar 2017 | Human Drugs | 483 | View 483 → |
| 6 Oct 2014 – 10 Oct 2014 | Human Drugs | Clean | |
| 7 Jul 2014 | Human Drugs | Clean | |
| 20 Sep 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Aug 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Bijoy Panicker, Robin P Mathew
8 Aug 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Bijoy Panicker, Robin P Mathew
4 Oct 2022
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Gam S Zamil, Mindy M Chou, Natasha Gupta
4 Oct 2022
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Gam S Zamil, Mindy M Chou, Natasha Gupta
Investigators
FDA investigators tied to this site in the record.
Bijoy Panicker1 insp.
Robin P Mathew1 insp.
Gam S Zamil1 insp.
Mindy M Chou1 insp.
Natasha Gupta1 insp.
Juan R Jimenez Garcia1 insp.
Samina S Khan1 insp.
Patric C Klotzbuecher1 insp.
Robert C Horan1 insp.
Kenneth G Klobus1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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 Steri-Pharma, LLC's 4 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