Auro Pharmacies, Inc.
Form 483 issued November 5, 2015 · La Hab r a, California
- Inspection
- Sep 22 – Nov 5, 2015
- Investigator
- Uttaniti Limchumroon
- Observations
- 9
- Pages
- 8
- FEI number
- 3011893599
In short: On November 5, 2015, FDA issued a Form 483 with 9 observations to Auro Pharmacies, Inc. in La Hab r a, California (FEI 3011893599) after an inspection that ran Sep 22 – Nov 5, 2015. The investigator was Uttaniti Limchumroon. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) 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 483sOther sites cited under 211.167(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Auro Pharmacies, Inc.?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. 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 Auro Pharmacies, Inc.?
Uttaniti Limchumroon is named on this Form 483, for the inspection of Sep 22 – Nov 5, 2015. Each investigator has a profile showing what they cite most.
When was Auro Pharmacies, Inc. inspected by FDA?
The inspection ran Sep 22 – Nov 5, 2015, and the Form 483 is dated November 5, 2015.
How do I get the full Form 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.