Pharmaceutical Laboratories and Consultants, Inc.
Form 483 issued October 10, 2017 · Addison, Illinois
- Inspection
- Sep 18 – Oct 10, 2017
- Investigator
- Christina A. Miller
- Observations
- 1
- Pages
- 13
- FEI number
- 3003982646
In short: On October 10, 2017, FDA issued a Form 483 with 1 observation to Pharmaceutical Laboratories and Consultants, Inc. in Addison, Illinois (FEI 3003982646) after an inspection that ran Sep 18 – Oct 10, 2017. The investigator was Christina A. Miller. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Christina A. Miller
10 documents · 2010–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Illinois.
The firmPharmaceutical Laboratories and Consultants, 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 211.165(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutical Laboratories and Consultants, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Pharmaceutical Laboratories and Consultants, Inc.?
Christina A. Miller is named on this Form 483, for the inspection of Sep 18 – Oct 10, 2017. Each investigator has a profile showing what they cite most.
When was Pharmaceutical Laboratories and Consultants, Inc. inspected by FDA?
The inspection ran Sep 18 – Oct 10, 2017, and the Form 483 is dated October 10, 2017.
How do I get the full Form 483 for Pharmaceutical Laboratories and Consultants, 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.