Rockline Industries, Inc
Form 483 issued May 4, 2018 · Sheboygan, Wisconsin
- Inspection
- May 1 – May 4, 2018
- Investigator
- Tenzin Jangchup
- Observations
- 1
- Pages
- 2
- FEI number
- 2129284
In short: On May 4, 2018, FDA issued a Form 483 with 1 observation to Rockline Industries, Inc in Sheboygan, Wisconsin (FEI 2129284) after an inspection that ran May 1 – May 4, 2018. The investigator was Tenzin Jangchup. Most observations concern materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.80(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are lacking which describe in sufficient detail the approval…
This inspection in context
Tenzin Jangchup
14 documents · 2015–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmRockline Industries, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.80(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rockline Industries, Inc?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Rockline Industries, Inc?
Tenzin Jangchup is named on this Form 483, for the inspection of May 1 – May 4, 2018. Each investigator has a profile showing what they cite most.
When was Rockline Industries, Inc inspected by FDA?
The inspection ran May 1 – May 4, 2018, and the Form 483 is dated May 4, 2018.
How do I get the full Form 483 for Rockline Industries, 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.