Overview
- 42 public-safe observations are available for this inspection.
- 20 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
28 Apr 2017
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Sonya L Karsik, Marcus F Yambot, Walden H Lee, Theresa Kirkham, Cassandra L Abellard
28 Apr 2017
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Sonya L Karsik, Marcus F Yambot, Walden H Lee, Theresa Kirkham, Cassandra L Abellard
28 Apr 2017
21 CFR 211.165(e)
Test methods
Cited by Sonya L Karsik, Marcus F Yambot, Walden H Lee, Theresa Kirkham, Cassandra L Abellard
28 Apr 2017
21 CFR 211.192
Written record of investigation incomplete
Cited by Sonya L Karsik, Marcus F Yambot, Walden H Lee, Theresa Kirkham, Cassandra L Abellard
28 Apr 2017
21 CFR 211.194(a)
Complete test data included in records
Cited by Sonya L Karsik, Marcus F Yambot, Walden H Lee, Theresa Kirkham, Cassandra L Abellard
Inspected site
SPSparsha Pharma Usa IncOceanside, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 42 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