Weatherford Compounding Pharmacy LLC
Form 483 issued August 2, 2024 · Weatherford, Texas
- Inspection
- Jul 23 – Aug 2, 2024
- Investigators
- Margaret M. Annes· Stephanie M. Mongeluzzi
- Observations
- 8
- Pages
- 10
- FEI number
- 3008790859
In short: On August 2, 2024, FDA issued a Form 483 with 8 observations to Weatherford Compounding Pharmacy LLC in Weatherford, Texas (FEI 3008790859) after an inspection that ran Jul 23 – Aug 2, 2024. The investigators were Margaret M. Annes and Stephanie M. Mongeluzzi. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Weatherford Compounding Pharmacy LLC?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected Weatherford Compounding Pharmacy LLC?
Margaret M. Annes and Stephanie M. Mongeluzzi are named on this Form 483, for the inspection of Jul 23 – Aug 2, 2024. Each investigator has a profile showing what they cite most.
When was Weatherford Compounding Pharmacy LLC inspected by FDA?
The inspection ran Jul 23 – Aug 2, 2024, and the Form 483 is dated August 2, 2024.
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.