Auro Pharmacies, Inc.
Form 483 issued July 9, 2018 · La Habra, California
- Inspection
- Jul 9, 2018
- Investigators
- Andrew K. Haack· Kenneth O. Gee
- Observations
- 10
- Pages
- 9
- FEI number
- 3011893599
In short: On July 9, 2018, FDA issued a Form 483 with 10 observations to Auro Pharmacies, Inc. in La Habra, California (FEI 3011893599) after an inspection that ran Jul 9, 2018. The investigators were Andrew K. Haack and Kenneth O. Gee. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 6 of 10 observations.
Most cited: 21 CFR 211.113 (4×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 classified aseptic processing areas had visibly…
- 02
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 03
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Andrew K. Haack
12 documents · 2017–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Auro Pharmacies, Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Auro Pharmacies, Inc.?
Andrew K. Haack and Kenneth O. Gee are named on this Form 483, for the inspection of Jul 9, 2018. Each investigator has a profile showing what they cite most.
When was Auro Pharmacies, Inc. inspected by FDA?
The inspection ran Jul 9, 2018, and the Form 483 is dated July 9, 2018.
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.