Microbiological Testing & Consulting
Form 483 issued July 27, 2016 · Joliet, Illinois
- Inspection
- Jul 13 – Jul 27, 2016
- Investigator
- Christina A. Miller
- Observations
- 5
- Pages
- 5
- FEI number
- 3003875820
In short: On July 27, 2016, FDA issued a Form 483 with 5 observations to Microbiological Testing & Consulting in Joliet, Illinois (FEI 3003875820) after an inspection that ran Jul 13 – Jul 27, 2016. The investigator was Christina A. Miller. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
5 of 5 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b)(4) (2×)
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…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
- 04
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
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 firmMicrobiological Testing & Consulting history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Microbiological Testing & Consulting?
FDA listed 5 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Microbiological Testing & Consulting?
Christina A. Miller is named on this Form 483, for the inspection of Jul 13 – Jul 27, 2016. Each investigator has a profile showing what they cite most.
When was Microbiological Testing & Consulting inspected by FDA?
The inspection ran Jul 13 – Jul 27, 2016, and the Form 483 is dated July 27, 2016.
How do I get the full Form 483 for Microbiological Testing & Consulting?
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.