Hallettsville Pharmacy, LLC
Form 483 issued November 8, 2018 · Hallettsville, Texas
- Inspection
- Nov 5 – Nov 8, 2018
- Investigator
- Stephen D. Brown
- Observations
- 2
- Pages
- 2
- FEI number
- 3014538927
In short: On November 8, 2018, FDA issued a Form 483 with 2 observations to Hallettsville Pharmacy, LLC in Hallettsville, Texas (FEI 3014538927) after an inspection that ran Nov 5 – Nov 8, 2018. The investigator was Stephen D. Brown. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm produced highly potent drugs without providing adequate cleaning of work surfaces and…
- 02
Non-pharmaceutical grade components are used in the formulation…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmHallettsville Pharmacy, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hallettsville Pharmacy, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Hallettsville Pharmacy, LLC?
Stephen D. Brown is named on this Form 483, for the inspection of Nov 5 – Nov 8, 2018. Each investigator has a profile showing what they cite most.
When was Hallettsville Pharmacy, LLC inspected by FDA?
The inspection ran Nov 5 – Nov 8, 2018, and the Form 483 is dated November 8, 2018.
How do I get the full Form 483 for Hallettsville 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.