Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-23.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jun 2023 – 23 Jun 2023 | Human Drugs | 483 | View 483 → |
| 3 Jun 2019 – 14 Jun 2019 | Human Drugs | 483 | View 483 → |
| 6 Jul 2015 – 14 Jul 2015 | Human Drugs | 483 | View 483 → |
| 23 Jul 2013 – 31 Jul 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Jun 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Pratik S Upadhyay, Xiaokuang Lai
23 Jun 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Pratik S Upadhyay, Xiaokuang Lai
23 Jun 2023
21 CFR 211.194(a)
Complete test data included in records
Cited by Pratik S Upadhyay, Xiaokuang Lai
23 Jun 2023
21 CFR 211.198(b)(2)
Written record of complaint to include findings, follow-up
Cited by Pratik S Upadhyay, Xiaokuang Lai
Investigators
FDA investigators tied to this site in the record.
Pratik S Upadhyay1 insp.
Xiaokuang Lai1 insp.
Darren S Brown1 insp.
Junho Pak1 insp.
Susan T Hadman1 insp.
Sandra A Hughes1 insp.
Chad N Thompson1 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 | 9x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | 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)(i) | 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 211.42(c)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Laboratorio Reig Jofre Sa.'s 4 Form 483s
Source PDFs, verbatim observations, 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