PCI San Diego, Inc.
Form 483 issued May 9, 2025 · San Diego, California
- Inspection
- Apr 30 – May 9, 2025
- Investigators
- Elvis Patel· Jeffrey P. Raimondi· Junho Pak
- Observations
- 6
- Pages
- 32
- FEI number
- 3004575449
In short: On May 9, 2025, FDA issued a Form 483 with 6 observations to PCI San Diego, Inc. in San Diego, California (FEI 3004575449) after an inspection that ran Apr 30 – May 9, 2025. The investigators were Elvis Patel, Jeffrey P. Raimondi, Junho Pak, Kara J. Wright, Michael T. Cyrus and Scott D. McGrew. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Written records are not always made of…
This inspection in context
Elvis Patel
3 documents · 2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmPCI San Diego, Inc. history
All 13 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PCI San Diego, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected PCI San Diego, Inc.?
Elvis Patel, Jeffrey P. Raimondi, Junho Pak, Kara J. Wright, Michael T. Cyrus and Scott D. McGrew are named on this Form 483, for the inspection of Apr 30 – May 9, 2025. Each investigator has a profile showing what they cite most.
When was PCI San Diego, Inc. inspected by FDA?
The inspection ran Apr 30 – May 9, 2025, and the Form 483 is dated May 9, 2025.
How do I get the full Form 483 for PCI San Diego, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.