Pharmalogic Austin LLC
Form 483 issued November 21, 2024 · Austin, Texas
- Inspection
- Nov 18 – Nov 21, 2024
- Investigators
- Laurie Nelson· Laurimer Kuilan-Torres
- Observations
- 5
- Pages
- 4
- FEI number
- 3029262794
In short: On November 21, 2024, FDA issued a Form 483 with 5 observations to Pharmalogic Austin LLC in Austin, Texas (FEI 3029262794) after an inspection that ran Nov 18 – Nov 21, 2024. The investigators were Laurie Nelson and Laurimer Kuilan-Torres. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Production and laboratory controls account for 3 of 5 observations.
Most cited: 21 CFR 211.188 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not establish a written testing progr am to assess the stability characteristics…
- 02
You did not conduct identity testing on each lot of component that yields an active ingredient…
- 03
You did not implement procediues to ensure that all equipment is suitable for its intended purposes…
- 04
Yom batch production record did not include the dates of production steps and times…
This inspection in context
Laurie Nelson
2 documents · 2018–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmPharmalogic Austin LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmalogic Austin LLC?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Pharmalogic Austin LLC?
Laurie Nelson and Laurimer Kuilan-Torres are named on this Form 483, for the inspection of Nov 18 – Nov 21, 2024. Each investigator has a profile showing what they cite most.
When was Pharmalogic Austin LLC inspected by FDA?
The inspection ran Nov 18 – Nov 21, 2024, and the Form 483 is dated November 21, 2024.
How do I get the full Form 483 for Pharmalogic Austin 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.