Andrx Pharmaceuticals, Inc.
Form 483 issued April 18, 2006 · Fort Lauderdale, Florida
- Inspection
- Mar 6 – Apr 18, 2006
- Investigators
- Cecilia Rodriguez· Heurca Barreto-Pettit
- Observations
- 9
- Pages
- 11
- FEI number
- 3003194604
In short: On April 18, 2006, FDA issued a Form 483 with 9 observations to Andrx Pharmaceuticals, Inc. in Fort Lauderdale, Florida (FEI 3003194604) after an inspection that ran Mar 6 – Apr 18, 2006. The investigators were Cecilia Rodriguez and Heurca Barreto-Pettit. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and facilities & equipment account for 6 of 9 observations.
Most cited: 21 CFR 211.67 (3×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to review production records to assure that no errors have…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
The use of instruments and apparatus not meeting…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Cecilia Rodriguez
1 document · 2006
Cites 211.67 (equipment cleaning and maintenance) 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 211.67
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 quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Andrx Pharmaceuticals, Inc.?
Cecilia Rodriguez and Heurca Barreto-Pettit are named on this Form 483, for the inspection of Mar 6 – Apr 18, 2006. Each investigator has a profile showing what they cite most.
When was Andrx Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Mar 6 – Apr 18, 2006, and the Form 483 is dated April 18, 2006.
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.