PCI San Diego, Inc.
Form 483 issued September 20, 2023 · San Diego, California
- Investigator
- Cassandra L. Abellard
- Observations
- 3
- Pages
- 3
- FEI number
- 3004575449
In short: On September 20, 2023, FDA issued a Form 483 with 3 observations to PCI San Diego, Inc. in San Diego, California (FEI 3004575449). The investigator was Cassandra L. Abellard. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's microbial cross-contamination control in the(b) (4) vial filling machine and the (b) (4) filling…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Complaint records are deficient in that they do not include the findings of…
This inspection in context
Cassandra L. Abellard
6 documents · 2015–2023
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Puerto Rico.
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 production and quality system. 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.?
Cassandra L. Abellard is named on this Form 483. Each investigator has a profile showing what they cite most.
When was PCI San Diego, Inc. inspected by FDA?
This Form 483 is dated September 20, 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.