Leiter's Cambrian Park Drugs, Inc.
Form 483 issued November 5, 2013 · San Jose, California
- Inspection
- Oct 22 – Nov 5, 2013
- Investigators
- Jennifer H. Rhyu· Thomas J. Arista
- Observations
- 15
- Pages
- 18
- FEI number
- 3003434971
In short: On November 5, 2013, FDA issued a Form 483 with 15 observations to Leiter's Cambrian Park Drugs, Inc. in San Jose, California (FEI 3003434971) after an inspection that ran Oct 22 – Nov 5, 2013. The investigators were Jennifer H. Rhyu and Thomas J. Arista. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 10 of 15 observations.
Most cited: 21 CFR 211.42 (4×) · 211.113 (2×)
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 do not include…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
This inspection in context
Jennifer H. Rhyu
5 documents · 2009–2014
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmLeiter's Cambrian Park Drugs, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Leiter's Cambrian Park Drugs, Inc.?
FDA listed 15 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Leiter's Cambrian Park Drugs, Inc.?
Jennifer H. Rhyu and Thomas J. Arista are named on this Form 483, for the inspection of Oct 22 – Nov 5, 2013. Each investigator has a profile showing what they cite most.
When was Leiter's Cambrian Park Drugs, Inc. inspected by FDA?
The inspection ran Oct 22 – Nov 5, 2013, and the Form 483 is dated November 5, 2013.
How do I get the full Form 483 for Leiter's Cambrian Park Drugs, 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.