Allergan Sales LLC
Form 483 issued June 24, 2021 · Cincinnati, Ohio
- Inspection
- May 25 – Jun 24, 2021
- Investigators
- Lauren N. Howard· Logan T. Williams· Wen Ning Chan
- Observations
- 8
- Pages
- 13
- FEI number
- 1523957
In short: On June 24, 2021, FDA issued a Form 483 with 8 observations to Allergan Sales LLC in Cincinnati, Ohio (FEI 1523957) after an inspection that ran May 25 – Jun 24, 2021. The investigators were Lauren N. Howard, Logan T. Williams and Wen Ning Chan. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
5 of 8 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations, and assay necessary to…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods…
- 03
There is no written testing program designed to assess the stability…
- 04
***REPEAT OBSERVATION FROM 2019 FDA INSPECTION*** Laboratory controls do not include the establishment of scientifically sound…
This inspection in context
Lauren N. Howard
14 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Ohio.
The firmAllergan Sales 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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allergan Sales LLC?
FDA listed 8 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Allergan Sales LLC?
Lauren N. Howard, Logan T. Williams and Wen Ning Chan are named on this Form 483, for the inspection of May 25 – Jun 24, 2021. Each investigator has a profile showing what they cite most.
When was Allergan Sales LLC inspected by FDA?
The inspection ran May 25 – Jun 24, 2021, and the Form 483 is dated June 24, 2021.
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.