Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-30.
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 |
|---|---|---|---|
| 26 Aug 2024 – 30 Aug 2024 | Human Drugs | 483 | View 483 → |
| 3 Aug 2022 – 9 Aug 2022 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Aug 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Saundrea A Munroe, Mabany Lizardi
30 Aug 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Saundrea A Munroe, Mabany Lizardi
30 Aug 2024
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Saundrea A Munroe, Mabany Lizardi
9 Aug 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Saundrea A Munroe, Harshal J Desai, Navista C Bolton
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 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Profounda 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