PCI San Diego, Inc.
Form 483 issued February 7, 2019 · San Diego, California
- Inspection
- Jan 29 – Feb 7, 2019
- Investigator
- Omotunde O. Osunsanmi
- Observations
- 8
- Pages
- 7
- FEI number
- 3004575449
In short: On February 7, 2019, FDA issued a Form 483 with 8 observations to PCI San Diego, Inc. in San Diego, California (FEI 3004575449) after an inspection that ran Jan 29 – Feb 7, 2019. The investigator was Omotunde O. Osunsanmi. Most observations concern packaging & labeling and facilities & equipment; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
Packaging & labeling and facilities & equipment account for 5 of 8 observations.
Most cited: 21 CFR 211.122(d) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Written records of investigations into unexplained discrepancies do not include…
- 03
Samples taken of drug products for determination of conformance to written…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Omotunde O. Osunsanmi
13 documents · 2003–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in United Kingdom.
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 211.122(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PCI San Diego, Inc.?
FDA listed 8 observations on this Form 483, mostly about packaging & labeling, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected PCI San Diego, Inc.?
Omotunde O. Osunsanmi is named on this Form 483, for the inspection of Jan 29 – Feb 7, 2019. Each investigator has a profile showing what they cite most.
When was PCI San Diego, Inc. inspected by FDA?
The inspection ran Jan 29 – Feb 7, 2019, and the Form 483 is dated February 7, 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.