Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-01.
At a glance
Inspections
3
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jul 2025 – 1 Aug 2025 | Human Drugs | 483 | View 483 → |
| 9 Mar 2020 – 19 Mar 2020 | Human Drugs | 483 | On file |
| 12 Feb 2018 – 1 Mar 2018 | Human Drugs | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Aug 2025
21 CFR 211.192
No written record of investigation
Cited by Katherine E Jacobitz, Cecilia H Kieu, Aranjeet Singh
1 Aug 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Katherine E Jacobitz, Cecilia H Kieu, Aranjeet Singh
1 Aug 2025
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Katherine E Jacobitz, Cecilia H Kieu, Aranjeet Singh
19 Mar 2020
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Michele L Glendenning, Peng Zhou
Investigators
FDA investigators tied to this site in the record.
Katherine E Jacobitz1 insp.
Cecilia H Kieu1 insp.
Aranjeet Singh1 insp.
Michele L Glendenning1 insp.
Peng Zhou1 insp.
Michele L Obert1 insp.
Brett R Havranek1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Surmasis Pharmaceutical, 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