Andrx Pharmaceuticals, Inc.
Form 483 issued January 17, 2020 · Davie, Florida
- Inspection
- Jan 6 – Jan 17, 2020
- Observations
- 6
- Pages
- 6
- FEI number
- 3003194604
In short: On January 17, 2020, FDA issued a Form 483 with 6 observations to Andrx Pharmaceuticals, Inc. in Davie, Florida (FEI 3003194604) after an inspection that ran Jan 6 – Jan 17, 2020. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Deviations from production time limits are not justified and compromise the quality…
- 03
Employees are not given training in written procedures required by current…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located…
This inspection in context
Questions about this 483
What did FDA find at Andrx Pharmaceuticals, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
When was Andrx Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 6 – Jan 17, 2020, and the Form 483 is dated January 17, 2020.
How do I get the full Form 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.