Overview
- 11 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-18.
At a glance
Inspections
11
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Feb 2025 – 18 Feb 2025 | Human Drugs | WL | View 483 → |
| 3 Jun 2024 – 10 Jun 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Mar 2022 – 25 Mar 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Aug 2018 – 16 Aug 2018 | Human Drugs | 483 | View 483 → |
| 23 Feb 2015 – 25 Feb 2015 | Human Drugs | 483 | View 483 → |
| 19 Oct 2011 | Not recorded | 483 | On file |
| 31 Aug 2010 | Not recorded | 483 | View 483 → |
| 10 Nov 2009 | Not recorded | Clean | |
| 14 Mar 2008 | Not recorded | 483 | On file |
| 17 Aug 2005 | Not recorded | Clean | |
| 11 Aug 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Feb 2025
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Khoa Nathan V Tran
Investigators
FDA investigators tied to this site in the record.
Juanita Banuelos3 insp.
Khoa Nathan V Tran1 insp.
Nga T Ho1 insp.
Creighton T Tuzon1 insp.
Stephanie A Slater1 insp.
Roger F Zabinski1 insp.
Sangeeta M Khurana1 insp.
Comyar Shoghi1 insp.
Cntrctmntr Anderson1 insp.
Gene D Arcy1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medical Chemical Corporation's 8 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