Allergan Sales, LLC
Form 483 issued July 10, 2015 · Waco, Texas
- Inspection
- Jun 22 – Jul 10, 2015
- Investigators
- Latorie S. Jones· Massoud Motamed· Rebeca Rodriguez
- Observations
- 2
- Pages
- 4
- FEI number
- 1643525
In short: On July 10, 2015, FDA issued a Form 483 with 2 observations to Allergan Sales, LLC in Waco, Texas (FEI 1643525) after an inspection that ran Jun 22 – Jul 10, 2015. The investigators were Latorie S. Jones, Massoud Motamed, Rebeca Rodriguez and Shelby N. Marler. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allergan Sales, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Allergan Sales, LLC?
Latorie S. Jones, Massoud Motamed, Rebeca Rodriguez and Shelby N. Marler are named on this Form 483, for the inspection of Jun 22 – Jul 10, 2015. Each investigator has a profile showing what they cite most.
When was Allergan Sales, LLC inspected by FDA?
The inspection ran Jun 22 – Jul 10, 2015, and the Form 483 is dated July 10, 2015.
How do I get the full Form 483 for Allergan Sales, LLC?
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