Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-29.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Feb 2023 – 29 Mar 2023 | Foods & Cosmetics | Clean | |
| 23 Jan 2023 – 27 Jan 2023 | Foods & Cosmetics | 483 | View 483 → |
| 5 Jan 2021 – 23 Apr 2021 | Foods & Cosmetics | 483 | View 483 → |
| 5 Jan 2021 – 8 Jan 2021 | Foods & Cosmetics | Clean | |
| 24 Oct 2013 – 8 Nov 2013 | Foods & Cosmetics | Clean | |
| 27 Feb 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jan 2023
21 CFR 111.155(e)
Components - contamination, deterioration, mix-ups
Cited by Janet B Gray, Sandra R Saunders
27 Jan 2023
21 CFR 111.20(b)
Physical plant - space; equipment, materials
Cited by Janet B Gray, Sandra R Saunders
23 Apr 2021
21 CFR 111.180(b)(2)
Records - receiving; components, packaging, labels, products
Cited by Joseph F Owens, Marcella D Crook, Clinton V Giustra, Rashonda N Rucker, Robert Q Green
23 Apr 2021
21 CFR 111.20(h)
Physical plant - screening against pests
Cited by Joseph F Owens, Marcella D Crook, Clinton V Giustra, Rashonda N Rucker, Robert Q Green
Investigators
FDA investigators tied to this site in the record.
Joseph F Owens3 insp.
Marcella D Crook2 insp.
Clinton V Giustra2 insp.
Rashonda N Rucker2 insp.
Robert Q Green2 insp.
Janet B Gray1 insp.
Sandra R Saunders1 insp.
Robin N Goins1 insp.
Kenny R Robinson1 insp.
Ana L Kewes1 insp.
David T Glover1 insp.
Jimmy O Buford1 insp.
CntrctMntr A McBean1 insp.
Lareese K Thomas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.155(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(h) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hi-Tech Pharmaceuticals, Inc.'s 2 Form 483s
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