Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
5 Aug 2019
21 CFR 606.171
Biological product deviation report
Cited by Nikisha M Bolden, Erika M Wilkerson
5 Aug 2019
21 CFR 630.10(c)
Donor Eligibility on day of donation
Cited by Nikisha M Bolden, Erika M Wilkerson
Inspected site
CPCSL Plasma Inc.Philadelphia, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(e) | 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 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