Allergan Sales, LLC
Form 483 issued October 8, 2015 · Waco, Texas
- Inspection
- Sep 14 – Oct 8, 2015
- Investigators
- Diane Raccasi· Latorie S. Jones· Rebeca Rodriguez
- Observations
- 5
- Pages
- 3
- FEI number
- 1643525
In short: On October 8, 2015, FDA issued a Form 483 with 5 observations to Allergan Sales, LLC in Waco, Texas (FEI 1643525) after an inspection that ran Sep 14 – Oct 8, 2015. The investigators were Diane Raccasi, Latorie S. Jones and Rebeca Rodriguez. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program for drug products does not include sample size and test intervals based…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Clothing of personnel engaged in the manufacturing of drug products is not appropriate for…
This inspection in context
Diane Raccasi
5 documents · 2015–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allergan Sales, LLC?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Allergan Sales, LLC?
Diane Raccasi, Latorie S. Jones and Rebeca Rodriguez are named on this Form 483, for the inspection of Sep 14 – Oct 8, 2015. Each investigator has a profile showing what they cite most.
When was Allergan Sales, LLC inspected by FDA?
The inspection ran Sep 14 – Oct 8, 2015, and the Form 483 is dated October 8, 2015.
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.