Overview
- 19 public-safe observations are available for this inspection.
- 19 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
PLPrismic Lights International, Inc.Murfreesboro, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 111.15(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 111.205(a) | 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 111.260(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 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | 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 |
Full 483 report
Get the verbatim text of all 19 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere