TOLMAR, Inc.
Form 483 issued February 24, 2020 · Windsor, Colorado
- Inspection
- Feb 18 – Feb 24, 2020
- Investigator
- Zachary L. Stamm
- Observations
- 5
- Pages
- 8
- FEI number
- 3010755927
In short: On February 24, 2020, FDA issued a Form 483 with 5 observations to TOLMAR, Inc. in Windsor, Colorado (FEI 3010755927) after an inspection that ran Feb 18 – Feb 24, 2020. The investigator was Zachary L. Stamm. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
Equipment for adequate control over micro-organisms, humidity and temperature is not provided when appropriate for the…
This inspection in context
Zachary L. Stamm
13 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.
The firmTOLMAR, Inc. history
All 2 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 5 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected TOLMAR, Inc.?
Zachary L. Stamm is named on this Form 483, for the inspection of Feb 18 – Feb 24, 2020. Each investigator has a profile showing what they cite most.
When was TOLMAR, Inc. inspected by FDA?
The inspection ran Feb 18 – Feb 24, 2020, and the Form 483 is dated February 24, 2020.
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.