Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-11-27.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 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.
27 Nov 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Claudia M Perez-Kasmarski, Lena Nguyen, Navneet Kaur, Jason K Loo
27 Nov 2024
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Claudia M Perez-Kasmarski, Lena Nguyen, Navneet Kaur, Jason K Loo
27 Nov 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Claudia M Perez-Kasmarski, Lena Nguyen, Navneet Kaur, Jason K Loo
27 Nov 2024
21 CFR 211.166(a)
Lack of written stability program
Cited by Claudia M Perez-Kasmarski, Lena Nguyen, Navneet Kaur, Jason K Loo
27 Nov 2024
21 CFR 211.180(e)
Records reviewed annually
Cited by Claudia M Perez-Kasmarski, Lena Nguyen, Navneet Kaur, Jason K Loo
Investigators
FDA investigators tied to this site in the record.
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 | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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 1 Form 483
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