TOLMAR, Inc.
FDA inspection history in Windsor, Colorado, 2020 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–22Two Form 483s, at Windsor, Colorado.
- 2020The longest 483 on file: 5 observations over 8 pages at Windsor, Colorado.
Cited most
Across all TOLMAR observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.192Production record review1
- 21 CFR 211.46(b)Ventilation, air filtration, air heating and cooling1
The complete TOLMAR file.
All 2 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
Windsor, Colorado
Two Form 483s · 2020 to 2022 · 9 observations
Latest: Form 483, Jun 17, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-06-17 | 483 Form 483 | Windsor, Colorado | 4 | $99 |
| 2020-02-24 | 483 Form 483 | Windsor, Colorado | 5 | $99 |
Investigators on these documents
FEI number 3010755927 · most recent document Jun 17, 2022
About TOLMAR, Inc.
How many FDA Form 483s has TOLMAR, Inc. received?
FDA Intel has 2 Form 483s on file for TOLMAR, Inc.; the most recent is dated Jun 17, 2022.
When was TOLMAR, Inc. last inspected by FDA?
The most recent FDA inspection document on file for TOLMAR, Inc. is a Form 483 dated Jun 17, 2022, for the site in Windsor, Colorado.
What did FDA cite at TOLMAR, Inc.?
The regulations cited most in the observations on file for TOLMAR, Inc. are 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.