Amneal Pharmaceuticals of New York, LLC
Form 483 issued March 18, 2019 · Hauppauge, New York
- Inspection
- Mar 5 – Mar 18, 2019
- Investigator
- Alice S. Tsao
- Observations
- 1
- Pages
- 2
- FEI number
- 2434153
In short: On March 18, 2019, FDA issued a Form 483 with 1 observation to Amneal Pharmaceuticals of New York, LLC in Hauppauge, New York (FEI 2434153) after an inspection that ran Mar 5 – Mar 18, 2019. The investigator was Alice S. Tsao. Most observations concern materials; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.142(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products are not stored under appropriate conditions of humidity so that their identity, strength, quality…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmAmneal Pharmaceuticals of New York, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.142(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amneal Pharmaceuticals of New York, LLC?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected Amneal Pharmaceuticals of New York, LLC?
Alice S. Tsao is named on this Form 483, for the inspection of Mar 5 – Mar 18, 2019. Each investigator has a profile showing what they cite most.
When was Amneal Pharmaceuticals of New York, LLC inspected by FDA?
The inspection ran Mar 5 – Mar 18, 2019, and the Form 483 is dated March 18, 2019.
How do I get the full Form 483 for Amneal Pharmaceuticals of New York, 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.