Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-24.
At a glance
Inspections
9
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Oct 2023 – 24 Oct 2023 | Foods & Cosmetics | WL | View 483 → |
| 24 Sep 2018 – 10 Oct 2018 | Foods & Cosmetics | 483 | View 483 → |
| 13 Mar 2018 – 11 Apr 2018 | Foods & Cosmetics | 483 | View 483 → |
| 29 Aug 2016 – 21 Sep 2016 | Foods & Cosmetics | 483 | View 483 → |
| 12 Mar 2015 – 19 Mar 2015 | Foods & Cosmetics | 483 | View 483 → |
| 4 Feb 2014 – 18 Feb 2014 | Foods & Cosmetics | WL | View 483 → |
| 21 Mar 2011 | Not recorded | 483 | View 483 → |
| 23 Dec 2008 | Not recorded | Clean | |
| 1 Oct 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Oct 2023
21 CFR 111.127(a)
Quality control operations - labeling; visual examinations
Cited by Joseph C Yen
24 Oct 2023
21 CFR 111.205(b)(1)
Master manufacturing record-specifications; packaged, label
Cited by Joseph C Yen
Investigators
FDA investigators tied to this site in the record.
Natalie J Ayoub3 insp.
Thao T Kwan2 insp.
Joseph C Yen1 insp.
Aliza Chalapong Asawes1 insp.
Sundy Ven1 insp.
Cntrctmntr Nepsa1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.8 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.120(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.127(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.325(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.325(b)(2)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind West Coast Laboratories, Inc.'s 7 Form 483s
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