Tolmar, Inc.
FDA inspection history in Fort Collins, Colorado, 2017 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2020: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Fort Collins, Colorado.
- 2017The longest 483 on file: 2 observations over 4 pages at Fort Collins, Colorado.
- 2020One Form 483, at Fort Collins, Colorado.
- 2023One Form 483, at Fort Collins, Colorado.
Cited most
Across all Tolmar observations on file
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete Tolmar file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Fort Collins, Colorado
Three Form 483s · 2017 to 2023 · 4 observations
Latest: Form 483, Jan 31, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-31 | 483 Form 483 | Fort Collins, Colorado | 1 | $99 |
| 2020-01-28 | 483 Form 483 | Fort Collins, Colorado | 1 | $99 |
| 2017-12-06 | 483 Form 483 | Fort Collins, Colorado | 2 | $99 |
Investigators on these documents
Marcus F. Yambot (1)Rowena S. Nguyen (1)Sangeeta M. Khurana (1)Santiago Gallardo Johnson (1)
FEI number 3006218434 · most recent document Jan 31, 2023
About Tolmar, Inc.
How many FDA Form 483s has Tolmar, Inc. received?
FDA Intel has 3 Form 483s on file for Tolmar, Inc.; the most recent is dated Jan 31, 2023.
When was Tolmar, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Tolmar, Inc. is a Form 483 dated Jan 31, 2023, for the site in Fort Collins, Colorado.
What did FDA cite at Tolmar, Inc.?
The regulations cited most in the observations on file for Tolmar, Inc. are 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 1 time.