PCI San Diego, Inc.
Form 483 issued April 6, 2017 · San Diego, California
- Inspection
- Mar 28 – Apr 6, 2017
- Investigators
- Katherine E. Jacobitz· Lata Mathew
- Observations
- 3
- Pages
- 2
- FEI number
- 3004575449
In short: On April 6, 2017, FDA issued a Form 483 with 3 observations to PCI San Diego, Inc. in San Diego, California (FEI 3004575449) after an inspection that ran Mar 28 – Apr 6, 2017. The investigators were Katherine E. Jacobitz and Lata Mathew. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(a) (2×) · 211.67(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures for cleaning and maintenance fail to include parameters…
- 02
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by…
- 03
Established laboratory control mechanisms…
This inspection in context
Katherine E. Jacobitz
3 documents · 2017–2026
Cites 211.160(a) (general requirements) 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 211.160(a)
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 laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected PCI San Diego, Inc.?
Katherine E. Jacobitz and Lata Mathew are named on this Form 483, for the inspection of Mar 28 – Apr 6, 2017. Each investigator has a profile showing what they cite most.
When was PCI San Diego, Inc. inspected by FDA?
The inspection ran Mar 28 – Apr 6, 2017, and the Form 483 is dated April 6, 2017.
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.