Spartan Chemical Company, Inc.
Form 483 issued March 26, 2021 · Maumee, Ohio
- Inspection
- Mar 1 – Mar 26, 2021
- Observations
- 6
- Pages
- 8
- FEI number
- 3001451695
In short: On March 26, 2021, FDA issued a Form 483 with 6 observations to Spartan Chemical Company, Inc. in Maumee, Ohio (FEI 3001451695) after an inspection that ran Mar 1 – Mar 26, 2021. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Questions about this 483
What did FDA find at Spartan Chemical Company, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production 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 Mar 1 – Mar 26, 2021, and the Form 483 is dated March 26, 2021.
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.