Andrx Pharmaceuticals, Inc.
Form 483 issued July 19, 2018 · Davie, Florida
- Inspection
- Jul 9 – Jul 19, 2018
- Investigators
- Chiaochun J. Wang· Fabian N. Chaparro-Rodriguez· Ileana Barreto-Pettit
- Observations
- 10
- Pages
- 14
- FEI number
- 3003194604
In short: On July 19, 2018, FDA issued a Form 483 with 10 observations to Andrx Pharmaceuticals, Inc. in Davie, Florida (FEI 3003194604) after an inspection that ran Jul 9 – Jul 19, 2018. The investigators were Chiaochun J. Wang, Fabian N. Chaparro-Rodriguez, Ileana Barreto-Pettit and Jennifer L. Huntington. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Quality system and facilities & equipment account for 7 of 10 observations.
Most cited: 21 CFR 211.68 (2×) · 211.25 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Chiaochun J. Wang
2 documents · 2018
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Andrx Pharmaceuticals, Inc.?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Andrx Pharmaceuticals, Inc.?
Chiaochun J. Wang, Fabian N. Chaparro-Rodriguez, Ileana Barreto-Pettit and Jennifer L. Huntington are named on this Form 483, for the inspection of Jul 9 – Jul 19, 2018. Each investigator has a profile showing what they cite most.
When was Andrx Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jul 9 – Jul 19, 2018, and the Form 483 is dated July 19, 2018.
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.