Overview
- 6 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 May 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jeffrey P Raimondi, Michael T Cyrus, Khoa Nathan V Tran, Elvis Patel
9 May 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Jeffrey P Raimondi, Michael T Cyrus, Khoa Nathan V Tran, Elvis Patel
9 May 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jeffrey P Raimondi, Michael T Cyrus, Khoa Nathan V Tran, Elvis Patel
9 May 2025
21 CFR 211.192
No written record of investigation
Cited by Jeffrey P Raimondi, Michael T Cyrus, Khoa Nathan V Tran, Elvis Patel
9 May 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jeffrey P Raimondi, Michael T Cyrus, Khoa Nathan V Tran, Elvis Patel
Inspected site
PSPCI San Diego, Inc.San Diego, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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(c)(10)(v) | 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 6 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