Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-25.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Oct 2024 – 25 Oct 2024 | Human Drugs | WL | View 483 → |
| 9 Sep 2021 | Tobacco Products | Clean | |
| 17 Dec 2019 – 18 Dec 2019 | Tobacco Products | Clean | |
| 10 Dec 2018 – 14 Dec 2018 | Human Drugs | 483 | On file |
| 23 May 2017 – 24 May 2017 | Tobacco Products | Clean | |
| 14 Nov 2016 – 29 Nov 2016 | Human Drugs | 483 | View 483 → |
| 23 Feb 2012 | Not recorded | Clean | |
| 3 Aug 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Oct 2024
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Susan O Oladeji
Investigators
FDA investigators tied to this site in the record.
Susan O Oladeji3 insp.
Matthew R Mcnew1 insp.
Arthur G Hurst1 insp.
Kimberly C Delk-Brooks1 insp.
Emil P Wang1 insp.
Kenny R Robinson1 insp.
John D Lloyd1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | 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)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.196 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cosco International, Inc.'s 3 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