White House Pharmacy Inc. dba San Jose Compounding Pharmacy
Form 483 issued September 14, 2018 · San Jose, California
- Inspection
- Sep 4 – Sep 14, 2018
- Investigator
- Kristin M. Abaonza
- Observations
- 4
- Pages
- 5
- FEI number
- 3002946561
In short: On September 14, 2018, FDA issued a Form 483 with 4 observations to White House Pharmacy Inc. dba San Jose Compounding Pharmacy in San Jose, California (FEI 3002946561) after an inspection that ran Sep 4 – Sep 14, 2018. The investigator was Kristin M. Abaonza. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced beta-lactam mugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils…
- 02
You produced highly potent diugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of…
- 03
You produced hazardous diugs without providing adequate cleaning of work surfaces and cleaning of…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Kristin M. Abaonza
12 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmWhite House Pharmacy Inc. dba San Jose Compounding Pharmacy history
The site's inspection history, in date order.
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 White House Pharmacy Inc. dba San Jose Compounding Pharmacy?
FDA listed 4 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 White House Pharmacy Inc. dba San Jose Compounding Pharmacy?
Kristin M. Abaonza is named on this Form 483, for the inspection of Sep 4 – Sep 14, 2018. Each investigator has a profile showing what they cite most.
When was White House Pharmacy Inc. dba San Jose Compounding Pharmacy inspected by FDA?
The inspection ran Sep 4 – Sep 14, 2018, and the Form 483 is dated September 14, 2018.
How do I get the full Form 483 for White House Pharmacy Inc. dba San Jose Compounding Pharmacy?
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.