Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-24.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2023 – 24 Mar 2023 | Foods & Cosmetics | 483 | View 483 → |
| 5 Jan 2021 – 30 Mar 2021 | Foods & Cosmetics | 483 | On file |
| 24 Oct 2013 – 8 Nov 2013 | Foods & Cosmetics | Clean | |
| 29 Feb 2012 | Not recorded | Clean | |
| 8 Dec 2009 | Not recorded | Clean | |
| 12 Feb 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Mar 2023
21 CFR 111.105
Quality control - packaged, labeled
Cited by Joseph F Owens, Rashonda N Rucker, Crystal A Harlan, Brenda Rivera
24 Mar 2023
21 CFR 111.105(a)
Processes, specifications, written procedures
Cited by Joseph F Owens, Rashonda N Rucker, Crystal A Harlan, Brenda Rivera
24 Mar 2023
21 CFR 111.123(b)(1)
Quality control - components, identity specifications
Cited by Joseph F Owens, Rashonda N Rucker, Crystal A Harlan, Brenda Rivera
24 Mar 2023
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Joseph F Owens, Rashonda N Rucker, Crystal A Harlan, Brenda Rivera
24 Mar 2023
21 CFR 111.127(h)
QC operations - packaging, labeling; approving, rejecting
Cited by Joseph F Owens, Rashonda N Rucker, Crystal A Harlan, Brenda Rivera
Investigators
FDA investigators tied to this site in the record.
Joseph F Owens3 insp.
Ibad U Khan2 insp.
Rashonda N Rucker1 insp.
Crystal A Harlan1 insp.
Brenda Rivera1 insp.
Kunapuli T Madhusudhan1 insp.
Justin A Boyd1 insp.
Victoria L Palmer1 insp.
Robin N Goins1 insp.
Kenny R Robinson1 insp.
Amanda L Evanco1 insp.
Ana L Kewes1 insp.
David T Glover1 insp.
Jimmy O Buford1 insp.
CntrctMntr A McBean1 insp.
Seneca D Toms1 insp.
Lareese K Thomas1 insp.
Hai Lien T Phung1 insp.
Babatunde D Babalola1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.127(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(B) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hi-Tech Pharmaceuticals Inc.'s 2 Form 483s
Source PDFs 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