Tolmar, Inc.
Form 483 issued January 31, 2023 · Fort Collins, Colorado
- Inspection
- Jan 19 – Jan 31, 2023
- Investigators
- Rowena S. Nguyen· Sangeeta M. Khurana
- Observations
- 1
- Pages
- 4
- FEI number
- 3006218434
In short: On January 31, 2023, FDA issued a Form 483 with 1 observation to Tolmar, Inc. in Fort Collins, Colorado (FEI 3006218434) after an inspection that ran Jan 19 – Jan 31, 2023. The investigators were Rowena S. Nguyen and Sangeeta M. Khurana. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Rowena S. Nguyen
12 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tolmar, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Tolmar, Inc.?
Rowena S. Nguyen and Sangeeta M. Khurana are named on this Form 483, for the inspection of Jan 19 – Jan 31, 2023. Each investigator has a profile showing what they cite most.
When was Tolmar, Inc. inspected by FDA?
The inspection ran Jan 19 – Jan 31, 2023, and the Form 483 is dated January 31, 2023.
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.