Analytical Control Systems, Inc
Form 483 issued February 29, 2016 · Fishers, Indiana
- Inspection
- Feb 16 – Feb 29, 2016
- Investigator
- Joseph R. Strelnik
- Observations
- 6
- Pages
- 4
- FEI number
- 1825740
In short: On February 29, 2016, FDA issued a Form 483 with 6 observations to Analytical Control Systems, Inc in Fishers, Indiana (FEI 1825740) after an inspection that ran Feb 16 – Feb 29, 2016. The investigator was Joseph R. Strelnik. Most observations concern production & process controls and management controls.
At a glance
Production & process controls and management controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration…
- 03
Schedules for the adjustment, cleaning, and other maintenance of equipment…
- 04
A device master record…
This inspection in context
Joseph R. Strelnik
13 documents · 2011–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmAnalytical Control Systems, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Analytical Control Systems, Inc?
FDA listed 6 observations on this Form 483, mostly about production & process controls, management controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Analytical Control Systems, Inc?
Joseph R. Strelnik is named on this Form 483, for the inspection of Feb 16 – Feb 29, 2016. Each investigator has a profile showing what they cite most.
When was Analytical Control Systems, Inc inspected by FDA?
The inspection ran Feb 16 – Feb 29, 2016, and the Form 483 is dated February 29, 2016.
How do I get the full Form 483 for Analytical Control Systems, 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.