John W. Hollis Inc dba John Hollis Pharmacy
Form 483 issued March 21, 2014 · Nashville, Tennessee
- Inspection
- Feb 4 – Mar 21, 2014
- Investigators
- David P. Van Houten· Samantha J. Bradley
- Observations
- 11
- Pages
- 5
- FEI number
- 1000391015
In short: On March 21, 2014, FDA issued a Form 483 with 11 observations to John W. Hollis Inc dba John Hollis Pharmacy in Nashville, Tennessee (FEI 1000391015) after an inspection that ran Feb 4 – Mar 21, 2014. The investigators were David P. Van Houten and Samantha J. Bradley. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and facilities & equipment account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contaminlk"i.on of drug products pw;porting to be sterile do not include…
- 02
Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure…
- 03
Clothing ofperwnnel engaged in tbe manufacturing, proeessing. and packing of drug products is oot appropriate for…
- 04
Buildings used .in rrns manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
David P. Van Houten
1 document · 2014
Cites 211.42(a) (design and construction features) more than any other section. Most of their documents are for sites in Tennessee.
The firmJohn W. Hollis Inc dba John Hollis Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 John W. Hollis Inc dba John Hollis Pharmacy?
FDA listed 11 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. 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 John W. Hollis Inc dba John Hollis Pharmacy?
David P. Van Houten and Samantha J. Bradley are named on this Form 483, for the inspection of Feb 4 – Mar 21, 2014. Each investigator has a profile showing what they cite most.
When was John W. Hollis Inc dba John Hollis Pharmacy inspected by FDA?
The inspection ran Feb 4 – Mar 21, 2014, and the Form 483 is dated March 21, 2014.
How do I get the full Form 483 for John W. Hollis Inc dba John Hollis 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.