Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
9
Form 483s
4
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 13 Feb 2026 | Human Drugs | Clean | |
| 11 Mar 2024 – 21 Mar 2024 | Human Drugs | 483 | View 483 → |
| 30 Jan 2023 – 3 Feb 2023 | Human Drugs | 483 | View 483 → |
| 6 Nov 2017 – 9 Nov 2017 | Human Drugs | 483 | View 483 → |
| 19 May 2015 – 21 May 2015 | Human Drugs | Clean | |
| 26 Mar 2013 – 29 Mar 2013 | Human Drugs | Clean | |
| 17 Dec 2012 | Not recorded | Clean | |
| 25 Jan 2011 | Not recorded | Clean | |
| 22 Sep 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Mar 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Robert J Ham, Rafeeq A Habeeb, Travis V Hull
21 Mar 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Robert J Ham, Rafeeq A Habeeb, Travis V Hull
21 Mar 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Robert J Ham, Rafeeq A Habeeb, Travis V Hull
21 Mar 2024
21 CFR 211.194(a)
Complete test data included in records
Cited by Robert J Ham, Rafeeq A Habeeb, Travis V Hull
21 Mar 2024
21 CFR 211.194(a)(6)
Comparison of Test Results to Specifications
Cited by Robert J Ham, Rafeeq A Habeeb, Travis V Hull
Investigators
FDA investigators tied to this site in the record.
Robert J Ham2 insp.
Rafeeq A Habeeb2 insp.
Robert M Barbosa2 insp.
David A Paterson2 insp.
Lisa R Hilliard1 insp.
John D Mcintosh1 insp.
Travis V Hull1 insp.
Logan T Williams1 insp.
Larry K Austin1 insp.
Constantin Y Philopoulos1 insp.
Meisha R Waters1 insp.
Daniel J Gorski1 insp.
Helen B Ricalde1 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 | 3x |
| 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 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind KP Pharmaceutical Technology'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