Overview
- 13 public-safe observations are available for this inspection.
- 13 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.
28 Jan 2022
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Yvins Dezan, Jessica S Estriplet
28 Jan 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Yvins Dezan, Jessica S Estriplet
28 Jan 2022
21 CFR 211.125(d)
Destruction of excess labels with lot numbers
Cited by Yvins Dezan, Jessica S Estriplet
28 Jan 2022
21 CFR 211.130(e)
Packaging line inspection before use
Cited by Yvins Dezan, Jessica S Estriplet
28 Jan 2022
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Yvins Dezan, Jessica S Estriplet
Inspected site
SPSharp Packaging Services, LLCAllentown, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 13 observations
The source PDF, 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