Auro Pharmacies Inc.
Form 483 issued December 2, 2016 · La Habra, California
- Inspection
- Nov 1 – Dec 2, 2016
- Investigators
- Evelyn Wong· Uttaniti Limchumroon
- Observations
- 16
- Pages
- 12
- FEI number
- 3012228279
In short: On December 2, 2016, FDA issued a Form 483 with 16 observations to Auro Pharmacies Inc. in La Habra, California (FEI 3012228279) after an inspection that ran Nov 1 – Dec 2, 2016. The investigators were Evelyn Wong and Uttaniti Limchumroon. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.42 (2×) · 211.94 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
EM PI.OYEE(S) SIGNATURE OATEISSUEO Time limits are not established when appropriate for the completion of each…
- 04
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not…
This inspection in context
Evelyn Wong
3 documents · 2016–2018
Cites 211.160 (general requirements) 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 16 observations on this Form 483, mostly about production, materials and laboratory controls. 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.?
Evelyn Wong and Uttaniti Limchumroon are named on this Form 483, for the inspection of Nov 1 – Dec 2, 2016. Each investigator has a profile showing what they cite most.
When was Auro Pharmacies Inc. inspected by FDA?
The inspection ran Nov 1 – Dec 2, 2016, and the Form 483 is dated December 2, 2016.
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.