Optikem International, Inc.
FDA inspection history in Denver, Colorado, 2022 to 2024
- 2
- Warning letters
- 2
- Form 483s
Every document, by year
- Warning letter
- Form 483
2022: one Form 483; 2024: two warning letters and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s and two warning letters, at Denver, Colorado.
- 2024The longest 483 on file: 7 observations over 8 pages at Denver, Colorado.
Cited most
Across all Optikem International observations on file
- 21 CFR 820.30(f)Design controls3
- 21 CFR 820.72(a)Inspection, measuring, and test equipment2
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.120(b)Device labeling1
- 21 CFR 820.70(c)Production and process controls1
The complete Optikem International file.
All 4 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
Denver, Colorado
Two warning letters and two Form 483s · 2022 to 2024 · 9 observations
Latest: Warning letter, Aug 13, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-13 | Warning letter Warning letter | Denver, Colorado | — | $99 |
| 2024-06-20 | Warning letter Warning letter | Denver, Colorado | — | $99 |
| 2024-03-01 | 483 Form 483 | Denver, Colorado | 7 | $99 |
| 2022-07-11 | 483 Form 483 | Denver, Colorado | 2 | $99 |
Investigators on these documents
FEI number 1720129 · most recent document Aug 13, 2024
About Optikem International, Inc.
How many FDA Form 483s has Optikem International, Inc. received?
FDA Intel has 2 Form 483s on file for Optikem International, Inc.; the most recent is dated Mar 1, 2024.
When was Optikem International, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Optikem International, Inc. is a Form 483 dated Mar 1, 2024, for the site in Denver, Colorado.
What did FDA cite at Optikem International, Inc.?
The regulations cited most in the observations on file for Optikem International, Inc. are 21 CFR 820.30(f) (Design controls), 3 times; 21 CFR 820.72(a) (Inspection, measuring, and test equipment), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has Optikem International, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Optikem International, Inc.; the most recent is dated Aug 13, 2024.