Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-24.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Apr 2026 – 24 Apr 2026 | Human Drugs | 483 | View 483 → |
| 6 Apr 2026 – 10 Apr 2026 | Human Drugs | Clean | |
| 23 May 2022 – 31 May 2022 | Human Drugs | 483 | View 483 → |
| 29 Jan 2018 – 6 Feb 2018 | Human Drugs | WL | View 483 → |
| 11 Jul 2016 – 19 Jul 2016 | Human Drugs | 483 | On file |
| 14 Apr 2014 – 18 Apr 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Apr 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Justin A Boyd, Hung H Do
24 Apr 2026
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Justin A Boyd, Hung H Do
24 Apr 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Justin A Boyd, Hung H Do
Investigators
FDA investigators tied to this site in the record.
Justin A Boyd1 insp.
Hung H Do1 insp.
Ruben C Ayala1 insp.
Truong X Nguyen1 insp.
Rachel C Harrington1 insp.
Kham Phommachanh1 insp.
Zachery L Miller1 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 | 5x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | 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)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(3) | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | 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(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hanlim Pharm Co. Ltd.'s 5 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