Overview
- 22 FDA inspections are on record.
- 18 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-09.
At a glance
Inspections
22
Form 483s
18
EIRs
8
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Apr 2025 – 9 May 2025 | Human Drugs | 483 | View 483 → |
| 12 Sep 2023 – 20 Sep 2023 | Human Drugs | 483 | On file |
| 2 Feb 2023 – 9 Feb 2023 | Human Drugs | 483 | On file |
| 11 Jan 2023 – 16 Jan 2023 | Human Drugs | 483 | On file |
| 5 May 2021 – 25 May 2021 | Human Drugs | 483 | View 483 → |
| 16 Dec 2019 – 20 Dec 2019 | Human Drugs | 483 | On file |
| 12 Nov 2019 – 22 Nov 2019 | Human Drugs | 483 | View 483 → |
| 30 Jul 2019 – 7 Aug 2019 | Human Drugs | 483 | View 483 → |
| 18 Mar 2019 – 22 Mar 2019 | Human Drugs | 483 | On file |
| 29 Jan 2019 – 7 Feb 2019 | Biologics | 483 | View 483 → |
| 23 May 2017 – 1 Jun 2017 | Biologics | 483 | On file |
| 28 Mar 2017 – 6 Apr 2017 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Linda Thai4 insp.
Santiago Gallardo Johnson3 insp.
Joey V Quitania3 insp.
Omotunde O Osunsanmi3 insp.
Michael T Cyrus2 insp.
Yi Wang2 insp.
Michael Shanks2 insp.
Virgilio F Pacio2 insp.
Jeffrey P Raimondi1 insp.
Khoa Nathan V Tran1 insp.
Elvis Patel1 insp.
Taichun Qin1 insp.
Cassandra L Abellard1 insp.
Laurimer Kuilan-Torres1 insp.
Esther C Broner1 insp.
Christopher R Czajka1 insp.
Amir Alavi1 insp.
Virginia A Carroll1 insp.
Nayan J Patel1 insp.
Jennifer M Gogley1 insp.
Thuy T Nguyen1 insp.
Ashley N Queen1 insp.
Carrie A Hughes1 insp.
Lestine C Webb1 insp.
Katherine E Jacobitz1 insp.
Lata C Mathew1 insp.
Helen B Ricalde1 insp.
Grace Deneke1 insp.
Rebecca K Olin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(7) | 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) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PCI San Diego, Inc.'s 18 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat