Allergan Sales, LLC
Form 483 issued February 27, 2019 · Waco, Texas
- Inspection
- Jan 29 – Feb 27, 2019
- Investigator
- Stephen D. Brown
- Observations
- 3
- Pages
- 3
- FEI number
- 1643525
In short: On February 27, 2019, FDA issued a Form 483 with 3 observations to Allergan Sales, LLC in Waco, Texas (FEI 1643525) after an inspection that ran Jan 29 – Feb 27, 2019. The investigator was Stephen D. Brown. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
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 firmAllergan Sales, LLC history
All 4 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 Allergan Sales, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Allergan Sales, LLC?
Stephen D. Brown is named on this Form 483, for the inspection of Jan 29 – Feb 27, 2019. Each investigator has a profile showing what they cite most.
When was Allergan Sales, LLC inspected by FDA?
The inspection ran Jan 29 – Feb 27, 2019, and the Form 483 is dated February 27, 2019.
How do I get the full Form 483 for Allergan Sales, 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.