Andrx Pharmaceuticals, Inc.
Form 483 issued January 15, 2016 · Davie, Florida
- Inspection
- Jan 5 – Jan 15, 2016
- Investigators
- Ademola O. Daramola· Jogy George· Stephanie D. Crockett
- Observations
- 9
- Pages
- 19
- FEI number
- 3003194604
In short: On January 15, 2016, FDA issued a Form 483 with 9 observations to Andrx Pharmaceuticals, Inc. in Davie, Florida (FEI 3003194604) after an inspection that ran Jan 5 – Jan 15, 2016. The investigators were Ademola O. Daramola, Jogy George and Stephanie D. Crockett. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Written production and process control procedures are not documented at…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Ademola O. Daramola
11 documents · 2014–2018
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Andrx Pharmaceuticals, Inc.?
FDA listed 9 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Andrx Pharmaceuticals, Inc.?
Ademola O. Daramola, Jogy George and Stephanie D. Crockett are named on this Form 483, for the inspection of Jan 5 – Jan 15, 2016. Each investigator has a profile showing what they cite most.
When was Andrx Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 5 – Jan 15, 2016, and the Form 483 is dated January 15, 2016.
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.