Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-09.
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 |
|---|---|---|---|
| 16 Oct 2023 – 9 Nov 2023 | Human Drugs | 483 | View 483 → |
| 27 Jul 2021 – 3 Sep 2021 | Human Drugs | WL | View 483 → |
| 20 May 2019 – 20 Jun 2019 | Human Drugs | 483 | View 483 → |
| 18 Jul 2016 – 28 Jul 2016 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Nov 2023
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Joanne E King
Investigators
FDA investigators tied to this site in the record.
Joanne E King1 insp.
Jennifer Lalama1 insp.
Bonita S Chester1 insp.
Latorie S Jones1 insp.
Stephanie D Crockett1 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 | 3x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(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)(iii) | Cited across public-safe Form 483 observations | 2x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 2x |
| FDCA 503B(b)(2)(A) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hybrid Pharma LLC'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