Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-20.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 20 Mar 2026 | Human Drugs | 483 | View 483 → |
| 18 Feb 2020 – 6 Mar 2020 | Human Drugs | 483 | On file |
| 27 Oct 2016 – 1 Nov 2016 | Human Drugs | Clean | |
| 18 Mar 2008 | Not recorded | Clean | |
| 18 Nov 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Mar 2026
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Demario L Walls, Sarah E Venti, Nelson N Ayangho
20 Mar 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Demario L Walls, Sarah E Venti, Nelson N Ayangho
20 Mar 2026
FDCA 582(b)(4)
Systems in place to comply with verification requirements
Cited by Demario L Walls, Sarah E Venti, Nelson N Ayangho
Investigators
FDA investigators tied to this site in the record.
Demario L Walls1 insp.
Sarah E Venti1 insp.
Nelson N Ayangho1 insp.
Charles L Zhou1 insp.
Jacob G Lutz1 insp.
Bei Y He1 insp.
Emilie Kahn1 insp.
Tracey L Siebesma1 insp.
Patsy J Domingo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind The Harvard Drug Group LLC'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