Able Laboratories, Inc.
FDA inspection history in Cranbury, New Jersey, 2004 to 2015
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2004: one warning letter; 2005: one amended 483 and one Form 483; 2015: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2004–05One warning letter, one amended 483 and one Form 483, at Cranbury, New Jersey.
- 2005The longest 483 on file: 12 observations over 15 pages at Cranbury, New Jersey.
- 2015One amended 483, at Cranbury, New Jersey.
Cited most
Across all Able Laboratories observations on file
- 21 CFR 211.192Production record review5
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 314.81Other postmarketing reports3
- 21 CFR 211.160General requirements2
- 21 CFR 211.165Testing and release for distribution2
The complete Able Laboratories file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Cranbury, New Jersey
Two amended 483s and one Form 483 · 2005 to 2015 · 25 observations
Latest: Form 483, Jul 24, 2015 →
Also: one document not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-07-24 | Amended 483 Amended 483 | Cranbury, New Jersey | 1 | $99 |
| 2005-07-06 | Amended 483 Amended 483 | Cranbury, New Jersey | 12 | $99 |
| 2005-07-01 | 483 Form 483 | Cranbury, New Jersey | 12 | $99 |
| 2004-04-19 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
Nancy L. Rolli (3)Daniel J. Grabicki (1)Joanne Heim (1)K. Harmor (1)Marea K. Harmon (1)
FEI number 3004106764 · most recent document Jul 24, 2015
About Able Laboratories, Inc.
How many FDA Form 483s has Able Laboratories, Inc. received?
FDA Intel has 3 Form 483s on file for Able Laboratories, Inc.; the most recent is dated Jul 24, 2015.
When was Able Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Able Laboratories, Inc. is a Form 483 dated Jul 24, 2015, for the site in Cranbury, New Jersey.
What did FDA cite at Able Laboratories, Inc.?
The regulations cited most in the observations on file for Able Laboratories, Inc. are 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 314.81 (Other postmarketing reports), 3 times.
Has Able Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Able Laboratories, Inc.; the most recent is dated Apr 19, 2004.