Allergan Sales, LLC
Form 483 issued October 28, 2016 · Waco, Texas
- Inspection
- Oct 18 – Oct 28, 2016
- Investigators
- Ademola O. Daramola· Massoud Motamed
- Observations
- 9
- Pages
- 19
- FEI number
- 1643525
In short: On October 28, 2016, FDA issued a Form 483 with 9 observations to Allergan Sales, LLC in Waco, Texas (FEI 1643525) after an inspection that ran Oct 18 – Oct 28, 2016. The investigators were Ademola O. Daramola and Massoud Motamed. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.194 (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 a complete record of all data secured in the course of…
- 02
ENPLOYEE(S) SIGNATURE DATENSSUED Laboratory records do not include complete data derived from all tests, examinations and…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Ademola O. Daramola
11 documents · 2014–2018
Cites 211.42 (design and construction features) 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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allergan Sales, LLC?
FDA listed 9 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Allergan Sales, LLC?
Ademola O. Daramola and Massoud Motamed are named on this Form 483, for the inspection of Oct 18 – Oct 28, 2016. Each investigator has a profile showing what they cite most.
When was Allergan Sales, LLC inspected by FDA?
The inspection ran Oct 18 – Oct 28, 2016, and the Form 483 is dated October 28, 2016.
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.