Overview
- 12 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-22.
At a glance
Inspections
12
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Dec 2025 – 22 Dec 2025 | Human Drugs | 483 | View 483 → |
| 1 Dec 2023 – 15 Dec 2023 | Human Drugs | 483 | View 483 → |
| 17 Aug 2021 – 24 Aug 2021 | Human Drugs | 483 | View 483 → |
| 25 Sep 2019 – 30 Sep 2019 | Human Drugs | WL | View 483 → |
| 22 Mar 2016 – 24 Mar 2016 | Medical Devices & Rad Health | 483 | On file |
| 9 Nov 2015 – 16 Nov 2015 | Human Drugs | 483 | View 483 → |
| 23 Apr 2013 – 26 Apr 2013 | Medical Devices & Rad Health | 483 | On file |
| 23 Jul 2012 | Not recorded | 483 | View 483 → |
| 12 Aug 2010 | Not recorded | 483 | View 483 → |
| 25 Oct 2006 | Not recorded | Clean | |
| 27 Jun 2005 | Not recorded | Clean | |
| 5 May 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Dec 2025
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Kham Phommachanh, Tareq W Haddad
22 Dec 2025
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Kham Phommachanh, Tareq W Haddad
22 Dec 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Kham Phommachanh, Tareq W Haddad
22 Dec 2025
21 CFR 211.165(a)
Testing and release for distribution
Cited by Kham Phommachanh, Tareq W Haddad
Investigators
FDA investigators tied to this site in the record.
Liming Zhang2 insp.
Kham Phommachanh1 insp.
Tareq W Haddad1 insp.
Darren S Brown1 insp.
Cecilia H Kieu1 insp.
Juanita Banuelos1 insp.
Yasamin Ameri1 insp.
Dejon N Harris1 insp.
Diane C Van Leeuwen1 insp.
Caryn M Mcnab1 insp.
Virgilio F Pacio1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 11x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Blaine Labs Inc's 9 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