Alexza Pharmaceuticals, Inc
Form 483 issued May 21, 2015 · Mountain View, California
- Inspection
- May 18 – May 21, 2015
- Investigators
- Daniel J. Roberts· David Eng
- Observations
- 2
- Pages
- 2
- FEI number
- 3007119522
In short: On May 21, 2015, FDA issued a Form 483 with 2 observations to Alexza Pharmaceuticals, Inc in Mountain View, California (FEI 3007119522) after an inspection that ran May 18 – May 21, 2015. The investigators were Daniel J. Roberts and David Eng. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy did not extend to other drug products that may have been…
- 0221 CFR 211.68(b)21 CFR 11
Input to and output from the computer and records or data are not checked for accuracy…
This inspection in context
Daniel J. Roberts
14 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAlexza Pharmaceuticals, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alexza Pharmaceuticals, Inc?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Alexza Pharmaceuticals, Inc?
Daniel J. Roberts and David Eng are named on this Form 483, for the inspection of May 18 – May 21, 2015. Each investigator has a profile showing what they cite most.
When was Alexza Pharmaceuticals, Inc inspected by FDA?
The inspection ran May 18 – May 21, 2015, and the Form 483 is dated May 21, 2015.
How do I get the full Form 483 for Alexza Pharmaceuticals, 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.