Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-05-08.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Apr 2015 – 8 May 2015 | Foods & Cosmetics | 483 | View 483 → |
| 4 Feb 2013 – 7 Feb 2013 | Foods & Cosmetics | 483 | On file |
| 23 Jan 2012 | Not recorded | 483 | View 483 → |
| 7 May 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 May 2015
21 CFR 111.105(i)
QC - required operations master manufacturing/batch records
Cited by Justin N Henson, Lindsay H Bertling
8 May 2015
21 CFR 111.123(b)(1)
Quality control - components, identity specifications
Cited by Justin N Henson, Lindsay H Bertling
8 May 2015
21 CFR 111.15(d)(1)
Animals and pests in facility
Cited by Justin N Henson, Lindsay H Bertling
8 May 2015
21 CFR 111.180(b)(3)(ii)(B)
Documentation - required operation; initials
Cited by Justin N Henson, Lindsay H Bertling
8 May 2015
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Justin N Henson, Lindsay H Bertling
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(3)(ii)(B) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.23(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(a) | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(3)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.460(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | 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 111.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Prismic Lights 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