FVS Holdings, Inc. (dba Green Valley Drugs)
Form 483 issued March 15, 2013 · Henderson, Nevada
- Inspection
- Mar 11 – Mar 15, 2013
- Investigators
- Henry K. Lau· Joshua S. Hunt· Rachel C. Harrington
- Observations
- 13
- Pages
- 7
- FEI number
- 3006306504
In short: On March 15, 2013, FDA issued a Form 483 with 13 observations to FVS Holdings, Inc. (dba Green Valley Drugs) in Henderson, Nevada (FEI 3006306504) after an inspection that ran Mar 11 – Mar 15, 2013. The investigators were Henry K. Lau, Joshua S. Hunt and Rachel C. Harrington. Most observations concern production and laboratory controls; 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 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 02
There was a failure to handle and store drug product containers at all times in a…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Henry K. Lau
5 documents · 2011–2016
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmFVS Holdings, Inc. (dba Green Valley Drugs) 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 FVS Holdings, Inc. (dba Green Valley Drugs)?
FDA listed 13 observations on this Form 483, mostly about production, laboratory controls and 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 FVS Holdings, Inc. (dba Green Valley Drugs)?
Henry K. Lau, Joshua S. Hunt and Rachel C. Harrington are named on this Form 483, for the inspection of Mar 11 – Mar 15, 2013. Each investigator has a profile showing what they cite most.
When was FVS Holdings, Inc. (dba Green Valley Drugs) inspected by FDA?
The inspection ran Mar 11 – Mar 15, 2013, and the Form 483 is dated March 15, 2013.
How do I get the full Form 483 for FVS Holdings, Inc. (dba Green Valley Drugs)?
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.