Al ere San Diego, Inc
Form 483 issued June 5, 2015 · San Diego, California
- Inspection
- Apr 13 – Jun 5, 2015
- Investigator
- Scott K. Zika
- Observations
- 5
- Pages
- 7
- FEI number
- 1000125596
In short: On June 5, 2015, FDA issued a Form 483 with 5 observations to Al ere San Diego, Inc in San Diego, California (FEI 1000125596) after an inspection that ran Apr 13 – Jun 5, 2015. The investigator was Scott K. Zika. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
2 of 3 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.50 (2×) · 803.50 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 04
Potential contractors were not evaluated based on their ability…
- 05
Records of acceptable contractors have…
This inspection in context
Scott K. Zika
7 documents · 2009–2018
Cites 803.50 (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in California.
The firmAl ere San Diego, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Al ere San Diego, Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Al ere San Diego, Inc?
Scott K. Zika is named on this Form 483, for the inspection of Apr 13 – Jun 5, 2015. Each investigator has a profile showing what they cite most.
When was Al ere San Diego, Inc inspected by FDA?
The inspection ran Apr 13 – Jun 5, 2015, and the Form 483 is dated June 5, 2015.
How do I get the full Form 483 for Al ere 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.