Spartan Chemical Company, Inc.
Form 483 issued December 12, 2022 · Maumee, Ohio
- Inspection
- Dec 5 – Dec 12, 2022
- Observations
- 4
- Pages
- 5
- FEI number
- 3001451695
In short: On December 12, 2022, FDA issued a Form 483 with 4 observations to Spartan Chemical Company, Inc. in Maumee, Ohio (FEI 3001451695) after an inspection that ran Dec 5 – Dec 12, 2022. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 02
Records associated with drug product production and within the retention period for such records, were not…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Questions about this 483
What did FDA find at Spartan Chemical Company, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
When was Spartan Chemical Company, Inc. inspected by FDA?
The inspection ran Dec 5 – Dec 12, 2022, and the Form 483 is dated December 12, 2022.
How do I get the full Form 483 for Spartan Chemical Company, 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.