TOLMAR, Inc.
Form 483 issued June 17, 2022 · Windsor, Colorado
- Inspection
- Jun 13 – Jun 17, 2022
- Investigator
- Michael T. Cyrus
- Observations
- 4
- Pages
- 4
- FEI number
- 3010755927
In short: On June 17, 2022, FDA issued a Form 483 with 4 observations to TOLMAR, Inc. in Windsor, Colorado (FEI 3010755927) after an inspection that ran Jun 13 – Jun 17, 2022. The investigator was Michael T. Cyrus. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Representative samples are not taken of each shipment of each lot of drug product containers…
- 03
The sensitivity of test methods…
- 04
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
This inspection in context
Michael T. Cyrus
12 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
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 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at TOLMAR, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected TOLMAR, Inc.?
Michael T. Cyrus is named on this Form 483, for the inspection of Jun 13 – Jun 17, 2022. Each investigator has a profile showing what they cite most.
When was TOLMAR, Inc. inspected by FDA?
The inspection ran Jun 13 – Jun 17, 2022, and the Form 483 is dated June 17, 2022.
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.