Auro Pharmacies Inc.
Form 483 issued June 29, 2017 · La Habra, California
- Inspection
- Jun 13 – Jun 29, 2017
- Investigator
- Liming Zhang
- Observations
- 13
- Pages
- 13
- FEI number
- 3012228279
In short: On June 29, 2017, FDA issued a Form 483 with 13 observations to Auro Pharmacies Inc. in La Habra, California (FEI 3012228279) after an inspection that ran Jun 13 – Jun 29, 2017. The investigator was Liming Zhang. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.113(b) (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods…
- 03
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Liming Zhang
19 documents · 2014–2021
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Auro Pharmacies Inc.?
FDA listed 13 observations on this Form 483, mostly about laboratory controls, quality system and production. 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.?
Liming Zhang is named on this Form 483, for the inspection of Jun 13 – Jun 29, 2017. Each investigator has a profile showing what they cite most.
When was Auro Pharmacies Inc. inspected by FDA?
The inspection ran Jun 13 – Jun 29, 2017, and the Form 483 is dated June 29, 2017.
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.