UCSF Home Therapy Services
Form 483 issued September 12, 2014 · San Franc isco, California
- Inspection
- Aug 26 – Sep 12, 2014
- Investigators
- Alicia K. McKinsey· Jennifer H. Rhyu
- Observations
- 5
- Pages
- 4
- FEI number
- 3004714346
In short: On September 12, 2014, FDA issued a Form 483 with 5 observations to UCSF Home Therapy Services in San Franc isco, California (FEI 3004714346) after an inspection that ran Aug 26 – Sep 12, 2014. The investigators were Alicia K. McKinsey and Jennifer H. Rhyu. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of dmg products purporting to be sterile do not include…
- 02
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient-regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Alicia K. McKinsey
3 documents · 2014–2015
Cites 211.42(c)(10)(iv) (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmUCSF Home Therapy Services history
The site's inspection history, in date order.
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 UCSF Home Therapy Services?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment 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 UCSF Home Therapy Services?
Alicia K. McKinsey and Jennifer H. Rhyu are named on this Form 483, for the inspection of Aug 26 – Sep 12, 2014. Each investigator has a profile showing what they cite most.
When was UCSF Home Therapy Services inspected by FDA?
The inspection ran Aug 26 – Sep 12, 2014, and the Form 483 is dated September 12, 2014.
How do I get the full Form 483 for UCSF Home Therapy Services?
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.