Weatherford Compounding Pharmacy LLC
Form 483 issued February 3, 2012 · Weatherford, Texas
- Inspection
- Oct 3, 2011 – Feb 3, 2012
- Investigators
- Anh Lac· Stephen D. Brown
- Observations
- 5
- Pages
- 2
- FEI number
- 3008790859
In short: On February 3, 2012, FDA issued a Form 483 with 5 observations to Weatherford Compounding Pharmacy LLC in Weatherford, Texas (FEI 3008790859) after an inspection that ran Oct 3, 2011 – Feb 3, 2012. The investigators were Anh Lac and Stephen D. Brown. Most observations concern production and materials.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Documentation was not provided to demonstrate that your firm has conducted media fills to validate the…
- 02
Your finn failed to provide data to demonstrate that the dcpyrogeoa.tion of glass vials and closures…
- 03
Documentation was not provided to demonstrate that your firm has condo (~L(41 J after compounding of…
- 04
Your firm failed to conduct investigations of potency failures for the…
This inspection in context
Anh Lac
13 documents · 2012–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmWeatherford Compounding Pharmacy LLC 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Weatherford Compounding Pharmacy LLC?
FDA listed 5 observations on this Form 483, mostly about production, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Weatherford Compounding Pharmacy LLC?
Anh Lac and Stephen D. Brown are named on this Form 483, for the inspection of Oct 3, 2011 – Feb 3, 2012. Each investigator has a profile showing what they cite most.
When was Weatherford Compounding Pharmacy LLC inspected by FDA?
The inspection ran Oct 3, 2011 – Feb 3, 2012, and the Form 483 is dated February 3, 2012.
How do I get the full Form 483 for Weatherford Compounding Pharmacy LLC?
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.