PCI San Diego, Inc.
Form 483 issued November 22, 2019 · San Diego, California
- Inspection
- Nov 12 – Nov 22, 2019
- Investigator
- Joey V. Quitania
- Observations
- 4
- Pages
- 4
- FEI number
- 3004575449
In short: On November 22, 2019, FDA issued a Form 483 with 4 observations to PCI San Diego, Inc. in San Diego, California (FEI 3004575449) after an inspection that ran Nov 12 – Nov 22, 2019. The investigator was Joey V. Quitania. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
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 did not include…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Failure to maintain a backup file of data entered into the…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
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 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected PCI San Diego, Inc.?
Joey V. Quitania is named on this Form 483, for the inspection of Nov 12 – Nov 22, 2019. Each investigator has a profile showing what they cite most.
When was PCI San Diego, Inc. inspected by FDA?
The inspection ran Nov 12 – Nov 22, 2019, and the Form 483 is dated November 22, 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.