Spartan Chemical Company, Inc.
FDA inspection history in Maumee, Ohio, 2021 to 2022
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2021: one warning letter and one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–22Two Form 483s and one warning letter, at Maumee, Ohio.
- 2021The longest 483 on file: 6 observations over 8 pages at Maumee, Ohio.
Cited most
Across all Spartan Chemical Company observations on file
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.180(c)General requirements1
- 21 CFR 211.192Production record review1
The complete Spartan Chemical Company 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
Maumee, Ohio
Two Form 483s and one warning letter · 2021 to 2022 · 10 observations
Latest: Form 483, Dec 12, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-12 | 483 Form 483 | Maumee, Ohio | 4 | $99 |
| 2021-12-15 | Warning letter Warning letter | Maumee, Ohio | — | $99 |
| 2021-03-26 | 483 Form 483 | Maumee, Ohio | 6 | $99 |
FEI number 3001451695 · most recent document Dec 12, 2022
About Spartan Chemical Company, Inc.
How many FDA Form 483s has Spartan Chemical Company, Inc. received?
FDA Intel has 2 Form 483s on file for Spartan Chemical Company, Inc.; the most recent is dated Dec 12, 2022.
When was Spartan Chemical Company, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Spartan Chemical Company, Inc. is a Form 483 dated Dec 12, 2022, for the site in Maumee, Ohio.
What did FDA cite at Spartan Chemical Company, Inc.?
The regulations cited most in the observations on file for Spartan Chemical Company, Inc. are 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.84(d)(2) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time.
Has Spartan Chemical Company, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Spartan Chemical Company, Inc.; the most recent is dated Dec 15, 2021.