Able Laboratories, Inc.
Form 483 issued July 1, 2005 · Cranbury, New Jersey
- Inspection
- May 2 – Jul 1, 2005
- Investigators
- Daniel J. Grabicki· Joanne Heim· Marea K. Harmon
- Observations
- 12
- Pages
- 12
- FEI number
- 3004106764
In short: On July 1, 2005, FDA issued a Form 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 investigators were Daniel J. Grabicki, Joanne Heim, Marea K. Harmon and Nancy L. Rolli. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (3×) · 314.81 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 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 physical properties which, as…
- 04
An NDAField Alert Report was not submitted within three working days of receipt of information concerning…
This inspection in context
Daniel J. Grabicki
1 document · 2005
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 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 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 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Able Laboratories, Inc.?
Daniel J. Grabicki, Joanne Heim, Marea K. Harmon and Nancy L. Rolli are named on this Form 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 Form 483 is dated July 1, 2005.
How do I get the full Form 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.