PCI San Diego, Inc.
Form 483 issued February 9, 2023 · San Diego, California
- Inspection
- Feb 2 – Feb 9, 2023
- Observations
- 7
- Pages
- 6
- FEI number
- 3004575449
In short: On February 9, 2023, FDA issued a Form 483 with 7 observations to PCI San Diego, Inc. in San Diego, California (FEI 3004575449) after an inspection that ran Feb 2 – Feb 9, 2023. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological…
- 02
Your firm failed to exercise appropriate controls over computer or related systems to assure that only…
- 03
Quality control unit procedures and…
- 04
Your firm failed to establish an adequate system for monitoring environmental conditions…
This inspection in context
Questions about this 483
What did FDA find at PCI San Diego, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
When was PCI San Diego, Inc. inspected by FDA?
The inspection ran Feb 2 – Feb 9, 2023, and the Form 483 is dated February 9, 2023.
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.