Advanced Physician Solutions, Inc.
Form 483 issued January 16, 2015 · N Hollywood, California
- Inspection
- Jan 12 – Jan 16, 2015
- Investigators
- Binh T. Nguyen· Liming Zhang· Sangeeta M. Khurana
- Observations
- 10
- Pages
- 11
- FEI number
- 3005084110
In short: On January 16, 2015, FDA issued a Form 483 with 10 observations to Advanced Physician Solutions, Inc. in N Hollywood, California (FEI 3005084110) after an inspection that ran Jan 12 – Jan 16, 2015. The investigators were Binh T. Nguyen, Liming Zhang and Sangeeta M. Khurana. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Binh T. Nguyen
13 documents · 2009–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmAdvanced Physician Solutions, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Physician Solutions, Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production 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 Advanced Physician Solutions, Inc.?
Binh T. Nguyen, Liming Zhang and Sangeeta M. Khurana are named on this Form 483, for the inspection of Jan 12 – Jan 16, 2015. Each investigator has a profile showing what they cite most.
When was Advanced Physician Solutions, Inc. inspected by FDA?
The inspection ran Jan 12 – Jan 16, 2015, and the Form 483 is dated January 16, 2015.
How do I get the full Form 483 for Advanced Physician Solutions, 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.