Able Laboratories, Inc.
Amended 483 issued July 6, 2005 · Cranbury, New Jersey
- Inspection
- May 2 – Jul 1, 2005
- Investigator
- Nancy L. Rolli
- Observations
- 12
- Pages
- 15
- FEI number
- 3004106764
In short: On July 6, 2005, FDA issued a Amended 483 with 12 observations to Able Laboratories, Inc. in Cranbury, New Jersey (FEI 3004106764) after an inspection that ran May 2 – Jul 1, 2005. The investigator was Nancy L. Rolli. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 8 of 12 observations.
Most cited: 21 CFR 211.22 (2×) · 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 fully investigate errors…
- 02
Drug products failing to meet established standards, specifications, and quality control…
- 03
An annual report did not include reports of investigations involving chemical or physica! properties which, as…
- 04
receipt of information concerning a failure of specifications established for…
8 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Nancy L. Rolli
4 documents · 2005–2015
Cites 211.192 (production record review) 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 12 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. 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.?
Nancy L. Rolli is named on this Amended 483, for the inspection of May 2 – Jul 1, 2005. Each investigator has a profile showing what they cite most.
When was Able Laboratories, Inc. inspected by FDA?
The inspection ran May 2 – Jul 1, 2005, and the Amended 483 is dated July 6, 2005.
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.