Auro Pharmacies Inc.
Amended 483 issued October 18, 2019 · La Habra, California
- Inspection
- Sep 17 – Oct 18, 2019
- Investigator
- Bryan A. Galvez
- Observations
- 11
- Pages
- 9
- FEI number
- 3012228279
In short: On October 18, 2019, FDA issued a Amended 483 with 11 observations to Auro Pharmacies Inc. in La Habra, California (FEI 3012228279) after an inspection that ran Sep 17 – Oct 18, 2019. The investigator was Bryan A. Galvez. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and sampling plans…
- 04
The statistical quality contrnl criteria fail to include appropriate acceptance…
7 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Bryan A. Galvez
15 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmAuro Pharmacies Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Auro Pharmacies Inc.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Auro Pharmacies Inc.?
Bryan A. Galvez is named on this Amended 483, for the inspection of Sep 17 – Oct 18, 2019. Each investigator has a profile showing what they cite most.
When was Auro Pharmacies Inc. inspected by FDA?
The inspection ran Sep 17 – Oct 18, 2019, and the Amended 483 is dated October 18, 2019.
How do I get the full Amended 483 for Auro Pharmacies 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.