ABCO Laboratories, Inc
Form 483 issued September 25, 2015 · Fairfield, California
- Inspection
- Sep 15 – Sep 25, 2015
- Investigator
- Stephanie A. Slater
- Observations
- 13
- Pages
- 17
- FEI number
- 1000142677
In short: On September 25, 2015, FDA issued a Form 483 with 13 observations to ABCO Laboratories, Inc in Fairfield, California (FEI 1000142677) after an inspection that ran Sep 15 – Sep 25, 2015. The investigator was Stephanie A. Slater. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after…
This inspection in context
Stephanie A. Slater
20 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
The firmABCO Laboratories, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ABCO Laboratories, Inc?
FDA listed 13 observations on this Form 483, mostly about production, materials and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected ABCO Laboratories, Inc?
Stephanie A. Slater is named on this Form 483, for the inspection of Sep 15 – Sep 25, 2015. Each investigator has a profile showing what they cite most.
When was ABCO Laboratories, Inc inspected by FDA?
The inspection ran Sep 15 – Sep 25, 2015, and the Form 483 is dated September 25, 2015.
How do I get the full Form 483 for ABCO 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.