Molding Services of Illinois Inc
Form 483 issued August 30, 2016 · Olney, Illinois
- Inspection
- Jul 28 – Aug 30, 2016
- Investigator
- Mark G. Peterson
- Observations
- 6
- Pages
- 4
- FEI number
- 3001969315
In short: On August 30, 2016, FDA issued a Form 483 with 6 observations to Molding Services of Illinois Inc in Olney, Illinois (FEI 3001969315) after an inspection that ran Jul 28 – Aug 30, 2016. The investigator was Mark G. Peterson. Most observations concern production & process controls and records & documents; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and records & documents account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.25(b)21 CFR 820
Personnel training is not…
- 02
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
- 03
Procedures for changes to a process…
- 04
The device history record does not demonstrate that the device was manufactured in accordance with…
This inspection in context
Mark G. Peterson
1 document · 2016
Cites 820.70(b) (production and process controls) more than any other section. Most of their documents are for sites in Illinois.
The firmMolding Services of Illinois Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.25(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Molding Services of Illinois Inc?
FDA listed 6 observations on this Form 483, mostly about production & process controls, records & documents and management controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Molding Services of Illinois Inc?
Mark G. Peterson is named on this Form 483, for the inspection of Jul 28 – Aug 30, 2016. Each investigator has a profile showing what they cite most.
When was Molding Services of Illinois Inc inspected by FDA?
The inspection ran Jul 28 – Aug 30, 2016, and the Form 483 is dated August 30, 2016.
How do I get the full Form 483 for Molding Services of Illinois 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.