PCI San Diego, Inc.
Form 483 issued December 20, 2019 · San Diego, California
- Inspection
- Dec 16 – Dec 20, 2019
- Investigators
- Michael R. Shanks· Santiago Gallardo Johnson· Virginia A. Carroll
- Observations
- 3
- Pages
- 4
- FEI number
- 3004575449
In short: On December 20, 2019, FDA issued a Form 483 with 3 observations to PCI San Diego, Inc. in San Diego, California (FEI 3004575449) after an inspection that ran Dec 16 – Dec 20, 2019. The investigators were Michael R. Shanks, Santiago Gallardo Johnson and Virginia A. Carroll. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the process…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Michael R. Shanks
27 documents · 2017–2024
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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PCI San Diego, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected PCI San Diego, Inc.?
Michael R. Shanks, Santiago Gallardo Johnson and Virginia A. Carroll are named on this Form 483, for the inspection of Dec 16 – Dec 20, 2019. Each investigator has a profile showing what they cite most.
When was PCI San Diego, Inc. inspected by FDA?
The inspection ran Dec 16 – Dec 20, 2019, and the Form 483 is dated December 20, 2019.
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.