Auro Pharmacies, Inc.
Form 483 issued August 12, 2022 · La Habra, California
- Inspection
- Aug 4 – Aug 12, 2022
- Investigator
- Bryan A. Galvez
- Observations
- 2
- Pages
- 2
- FEI number
- 3011893599
In short: On August 12, 2022, FDA issued a Form 483 with 2 observations to Auro Pharmacies, Inc. in La Habra, California (FEI 3011893599) after an inspection that ran Aug 4 – Aug 12, 2022. The investigator was Bryan A. Galvez. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced hazardous chugs without providing adequate containment or cleaning of and work…
- 02
Non-microbial contamination was observed…
This 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 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Auro Pharmacies, Inc.?
FDA listed 2 observations on this Form 483, mostly about 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.?
Bryan A. Galvez is named on this Form 483, for the inspection of Aug 4 – Aug 12, 2022. Each investigator has a profile showing what they cite most.
When was Auro Pharmacies, Inc. inspected by FDA?
The inspection ran Aug 4 – Aug 12, 2022, and the Form 483 is dated August 12, 2022.
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.