Allergan Pharmaceuticals Ireland Unlimited
Form 483 issued January 30, 2025 · Westport, Ireland
- Investigators
- Saleem A. Akhtar· Tamil Arasu
- Observations
- 7
- Pages
- 22
- FEI number
- 3002806285
In short: On January 30, 2025, FDA issued a Form 483 with 7 observations to Allergan Pharmaceuticals Ireland Unlimited in Westport, Ireland (FEI 3002806285). The investigators were Saleem A. Akhtar and Tamil Arasu. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmAllergan Pharmaceuticals Ireland Unlimited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allergan Pharmaceuticals Ireland Unlimited?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Allergan Pharmaceuticals Ireland Unlimited?
Saleem A. Akhtar and Tamil Arasu are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Allergan Pharmaceuticals Ireland Unlimited inspected by FDA?
This Form 483 is dated January 30, 2025.
How do I get the full Form 483 for Allergan Pharmaceuticals Ireland Unlimited?
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.