Overview
- 23 public-safe observations are available for this inspection.
- 22 structured CFR citations are represented.
- 6 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Approve or reject procedures or specs
Cited by Joey V Quitania, Jennifer M Gogley, Comyar Shoghi, Carla J Lundi, Virgilio F Pacio, Kim L Thomas Cruse
Procedures not in writing, fully followed
Cited by Joey V Quitania, Jennifer M Gogley, Comyar Shoghi, Carla J Lundi, Virgilio F Pacio, Kim L Thomas Cruse
Training--operations, GMPs, written procedures
Cited by Joey V Quitania, Jennifer M Gogley, Comyar Shoghi, Carla J Lundi, Virgilio F Pacio, Kim L Thomas Cruse
Inadequate number of personnel
Cited by Joey V Quitania, Jennifer M Gogley, Comyar Shoghi, Carla J Lundi, Virgilio F Pacio, Kim L Thomas Cruse
Equipment Design, Size and Location
Cited by Joey V Quitania, Jennifer M Gogley, Comyar Shoghi, Carla J Lundi, Virgilio F Pacio, Kim L Thomas Cruse
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(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 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 23 observations
The source PDF and 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