Tolmar, Inc.
Form 483 issued January 28, 2020 · Fort Collins, Colorado
- Inspection
- Jan 15 – Jan 28, 2020
- Observations
- 1
- Pages
- 2
- FEI number
- 3006218434
In short: On January 28, 2020, FDA issued a Form 483 with 1 observation to Tolmar, Inc. in Fort Collins, Colorado (FEI 3006218434) after an inspection that ran Jan 15 – Jan 28, 2020. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Questions about this 483
What did FDA find at Tolmar, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Tolmar, Inc. inspected by FDA?
The inspection ran Jan 15 – Jan 28, 2020, and the Form 483 is dated January 28, 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.