Allergan Sales LLC
Form 483 issued July 29, 2019 · Cincinnati, Ohio
- Investigator
- Lauren N. Howard
- Observations
- 4
- Pages
- 8
- FEI number
- 1523957
In short: On July 29, 2019, FDA issued a Form 483 with 4 observations to Allergan Sales LLC in Cincinnati, Ohio (FEI 1523957). The investigator was Lauren N. Howard. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after…
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allergan Sales LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Allergan Sales LLC?
Lauren N. Howard is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Allergan Sales LLC inspected by FDA?
This Form 483 is dated July 29, 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.