Weatherford Compounding Pharmacy LLC
Form 483 issued June 14, 2017 · Weatherford, Texas
- Inspection
- May 31 – Jun 14, 2017
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 5
- Pages
- 4
- FEI number
- 3008790859
In short: On June 14, 2017, FDA issued a Form 483 with 5 observations to Weatherford Compounding Pharmacy LLC in Weatherford, Texas (FEI 3008790859) after an inspection that ran May 31 – Jun 14, 2017. The investigator was Patty P. Kaewussdangkul. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Drug product were not sterilized and processed to remove pyrogenic properties to assure that they are…
- 03
Protective apparel is not worn as necessary to protect…
- 04
Your firm's products are intended to prevent, mitigate or treat diseases in animals, they are drugs…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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(b)
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, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Weatherford Compounding Pharmacy LLC?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of May 31 – Jun 14, 2017. Each investigator has a profile showing what they cite most.
When was Weatherford Compounding Pharmacy LLC inspected by FDA?
The inspection ran May 31 – Jun 14, 2017, and the Form 483 is dated June 14, 2017.
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.