Overview
- 26 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-21.
At a glance
Inspections
26
Form 483s
12
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Nov 2022 – 21 Dec 2022 | Human Drugs | 483 | View 483 → |
| 23 Jan 2019 – 13 Feb 2019 | Human Drugs | 483 | View 483 → |
| 19 Jul 2017 – 20 Jul 2017 | Human Drugs | Clean | |
| 19 Apr 2017 – 5 May 2017 | Human Drugs | 483 | View 483 → |
| 6 Jul 2016 – 15 Jul 2016 | Human Drugs | 483 | View 483 → |
| 24 Jun 2015 – 20 Jul 2015 | Human Drugs | 483 | View 483 → |
| 9 Oct 2013 – 30 Oct 2013 | Human Drugs | 483 | View 483 → |
| 13 Dec 2012 | Not recorded | 483 | On file |
| 19 Oct 2011 | Not recorded | 483 | View 483 → |
| 12 Nov 2010 | Not recorded | 483 | View 483 → |
| 3 Dec 2009 | Not recorded | 483 | On file |
| 16 Mar 2009 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Dec 2022
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Erik W Koester, Daniel L Zheng
21 Dec 2022
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Erik W Koester, Daniel L Zheng
21 Dec 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Erik W Koester, Daniel L Zheng
Investigators
FDA investigators tied to this site in the record.
Robert C Steyert4 insp.
James A Liubicich4 insp.
Alice S Tsao2 insp.
Robert C Horan2 insp.
Erik W Koester1 insp.
Daniel L Zheng1 insp.
Jay T Wong1 insp.
Samina S Khan1 insp.
Jose O Hernandez1 insp.
Sony Mathews1 insp.
Mindy M Chou1 insp.
Helen B Ricalde1 insp.
Marie B Buen-Bigornia1 insp.
Felix Maldonado1 insp.
Nariman Patenaude1 insp.
Gary J Lehr1 insp.
Nazmul Hassan1 insp.
Andrew M Abramowitz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | 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)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hi-Tech Pharmacal, an AKORN Company's 12 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