Able Laboratories, Inc.
Amended 483 issued July 24, 2015 · Cranbury, New Jersey
- Inspection
- May 3 – May 26, 2005
- Investigators
- K. Harmor· Nancy L. Rolli
- Observations
- 1
- Pages
- 15
- FEI number
- 3004106764
In short: On July 24, 2015, FDA issued a Amended 483 with 1 observation to Able Laboratories, Inc. in Cranbury, New Jersey (FEI 3004106764) after an inspection that ran May 3 – May 26, 2005. The investigators were K. Harmor and Nancy L. Rolli. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this amended 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
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 fully investigate…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
K. Harmor
1 document · 2015
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmAble Laboratories, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Able Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Able Laboratories, Inc.?
K. Harmor and Nancy L. Rolli are named on this Amended 483, for the inspection of May 3 – May 26, 2005. Each investigator has a profile showing what they cite most.
When was Able Laboratories, Inc. inspected by FDA?
The inspection ran May 3 – May 26, 2005, and the Amended 483 is dated July 24, 2015.
How do I get the full Amended 483 for Able Laboratories, 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.