Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-03-30.
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 |
|---|---|---|---|
| 21 Mar 2022 – 30 Mar 2022 | Biologics | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Mar 2022
21 CFR 1271.180(a)
Procedures to meet core CTGP
Cited by Bradley E Benasutti, Thai D Truong
30 Mar 2022
21 CFR 1271.260(e)
Storage temperatures recorded, maintained
Cited by Bradley E Benasutti, Thai D Truong
30 Mar 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Bradley E Benasutti, Thai D Truong
30 Mar 2022
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Bradley E Benasutti, Thai D Truong
Investigators
FDA investigators tied to this site in the record.
Bradley E Benasutti1 insp.
Thai D Truong1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Row1 Inc. dba Regenative Labs' 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