Tolmar, Inc.
Form 483 issued December 6, 2017 · Fort Collins, Colorado
- Inspection
- Nov 28 – Dec 6, 2017
- Investigators
- Marcus F. Yambot· Santiago Gallardo Johnson
- Observations
- 2
- Pages
- 4
- FEI number
- 3006218434
In short: On December 6, 2017, FDA issued a Form 483 with 2 observations to Tolmar, Inc. in Fort Collins, Colorado (FEI 3006218434) after an inspection that ran Nov 28 – Dec 6, 2017. The investigators were Marcus F. Yambot and Santiago Gallardo Johnson. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.68(b) (1×) · 211.84(d)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Marcus F. Yambot
16 documents · 2009–2023
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmTolmar, 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 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tolmar, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Tolmar, Inc.?
Marcus F. Yambot and Santiago Gallardo Johnson are named on this Form 483, for the inspection of Nov 28 – Dec 6, 2017. Each investigator has a profile showing what they cite most.
When was Tolmar, Inc. inspected by FDA?
The inspection ran Nov 28 – Dec 6, 2017, and the Form 483 is dated December 6, 2017.
How do I get the full Form 483 for Tolmar, 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.