Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-12.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jun 2026 – 12 Jun 2026 | Human Drugs | 483 | View 483 → |
| 18 Nov 2024 – 27 Nov 2024 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Jun 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Ngozi G Offor, Journey V Cordero
12 Jun 2026
21 CFR 211.166(a)
Lack of written stability program
Cited by Ngozi G Offor, Journey V Cordero
12 Jun 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Ngozi G Offor, Journey V Cordero
Investigators
FDA investigators tied to this site in the record.
Ngozi G Offor1 insp.
Journey V Cordero1 insp.
Claudia M Perez-Kasmarski1 insp.
Lena Nguyen1 insp.
Navneet Kaur1 insp.
Jason K Loo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | 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 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Product Society LLC'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