Andrx Pharmaceuticals, Inc.
Amended 483 issued May 25, 2021 · Davie, Florida
- Inspection
- May 25, 2021
- Investigators
- Jennifer L. Huntington· Joanne E. King
- Observations
- 1
- Pages
- 7
- FEI number
- 3003194604
In short: On May 25, 2021, FDA issued a Amended 483 with 1 observation to Andrx Pharmaceuticals, Inc. in Davie, Florida (FEI 3003194604) after an inspection that ran May 25, 2021. The investigators were Jennifer L. Huntington and Joanne E. King. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this amended 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmAndrx Pharmaceuticals, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Andrx Pharmaceuticals, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Andrx Pharmaceuticals, Inc.?
Jennifer L. Huntington and Joanne E. King are named on this Amended 483, for the inspection of May 25, 2021. Each investigator has a profile showing what they cite most.
When was Andrx Pharmaceuticals, Inc. inspected by FDA?
The inspection ran May 25, 2021, and the Amended 483 is dated May 25, 2021.
How do I get the full Amended 483 for Andrx Pharmaceuticals, Inc.?
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.