Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-21.
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 |
|---|---|---|---|
| 11 Sep 2023 – 21 Sep 2023 | Biologics | 483 | View 483 → |
| 19 Jul 2021 – 28 Jul 2021 | Biologics | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Sep 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by William F Lagud, Emily S Mcgann
21 Sep 2023
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by William F Lagud, Emily S Mcgann
21 Sep 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by William F Lagud, Emily S Mcgann
21 Sep 2023
21 CFR 211.166(a)
Lack of written stability program
Cited by William F Lagud, Emily S Mcgann
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 | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.12 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Re-Gen Active Lab 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