Overview
- 4 public-safe observations are available for this inspection.
- 1 structured CFR citation is represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
7 Aug 2018
FDCA 501(a)(2)(A)
Beta-lactam drugs, inadequate sanitation
Cited by Russell J Glapion, Sena G Dissmeyer
7 Aug 2018
FDCA 501(a)(2)(A)
Exposure of personnel in aspectic processing
Cited by Russell J Glapion, Sena G Dissmeyer
7 Aug 2018
FDCA 501(a)(2)(A)
Inadequate sporicidal agents, cleanroom and ISO 5 area
Cited by Russell J Glapion, Sena G Dissmeyer
7 Aug 2018
FDCA 501(a)(2)(A)
Personnel contact outside ISO 5 area
Cited by Russell J Glapion, Sena G Dissmeyer
Inspected site
PLPharmScript, LLCSomerset, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 4x |
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 4 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