ABCO Laboratories, Inc
FDA inspection history in Fairfield, California, 2011 to 2015
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2011: one warning letter; 2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter, at Fairfield, California.
- 2015One Form 483, at Fairfield, California.
Cited most
Across all ABCO Laboratories observations on file
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.80(a)General requirements2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.111Time limitations on production1
The complete ABCO Laboratories file.
All 2 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
Fairfield, California
One Form 483 and one warning letter · 2011 to 2015 · 13 observations
Latest: Form 483, Sep 25, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-09-25 | 483 Form 483 | Fairfield, California | 13 | $99 |
| 2011-09-09 | Warning letter Warning letter | Fairfield, California | — | $99 |
Investigators on these documents
FEI number 1000142677 · most recent document Sep 25, 2015
About ABCO Laboratories, Inc
How many FDA Form 483s has ABCO Laboratories, Inc received?
FDA Intel has 1 Form 483 on file for ABCO Laboratories, Inc; the most recent is dated Sep 25, 2015.
When was ABCO Laboratories, Inc last inspected by FDA?
The most recent FDA inspection document on file for ABCO Laboratories, Inc is a Form 483 dated Sep 25, 2015, for the site in Fairfield, California.
What did FDA cite at ABCO Laboratories, Inc?
The regulations cited most in the observations on file for ABCO Laboratories, Inc are 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.80(a) (General requirements), 2 times.
Has ABCO Laboratories, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for ABCO Laboratories, Inc; the most recent is dated Sep 9, 2011.