Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-06-30.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jun 2023 – 30 Jun 2023 | Human Drugs | WL | View 483 → |
| 10 Dec 2019 – 12 Dec 2019 | Biologics | Clean | |
| 14 Aug 2017 | Biologics | Clean | |
| 31 Aug 2015 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Jun 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Ivan E Reyes, Travis S Bradley, Samantha J Pinizzotto
30 Jun 2023
21 CFR 211.160(b)(1)
Samples (various types) representative, identified properly
Cited by Ivan E Reyes, Travis S Bradley, Samantha J Pinizzotto
30 Jun 2023
21 CFR 211.166(a)
Results not used for expiration dates, storage cond.
Cited by Ivan E Reyes, Travis S Bradley, Samantha J Pinizzotto
30 Jun 2023
21 CFR 211.170(b)(1)
Retention time of reserve samples, in general
Cited by Ivan E Reyes, Travis S Bradley, Samantha J Pinizzotto
30 Jun 2023
21 CFR 211.180(b)
Record maintenance 1 year (except exempt OTC)
Cited by Ivan E Reyes, Travis S Bradley, Samantha J Pinizzotto
Investigators
FDA investigators tied to this site in the record.
Samantha J Pinizzotto4 insp.
Ivan E Reyes1 insp.
Travis S Bradley1 insp.
Cody D Rickman1 insp.
Lura D Baquero1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Regenerative Processing Plant, 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