Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-23.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2023 – 23 Mar 2023 | Human Drugs | 483 | View 483 → |
| 10 Feb 2022 | Foods & Cosmetics | Clean | |
| 16 Aug 2021 – 29 Oct 2021 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Mar 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Seneca D Toms, Brittny C Cargo, Martrice A Packer
23 Mar 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Seneca D Toms, Brittny C Cargo, Martrice A Packer
23 Mar 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Seneca D Toms, Brittny C Cargo, Martrice A Packer
23 Mar 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Seneca D Toms, Brittny C Cargo, Martrice A Packer
23 Mar 2023
21 CFR 211.67(b)(2)
Cleaning SOPs/schedules
Cited by Seneca D Toms, Brittny C Cargo, Martrice A Packer
Investigators
FDA investigators tied to this site in the record.
Seneca D Toms1 insp.
Brittny C Cargo1 insp.
Martrice A Packer1 insp.
State Agency1 insp.
Vioela J Caze1 insp.
Vioela Respress1 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 | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind New Vision Pharmaceuticals LLC'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