Zochem LLC
Form 483 issued November 21, 2024 · Dickson, Tennessee
- Inspection
- Nov 18 – Nov 21, 2024
- Observations
- 4
- Pages
- 4
- FEI number
- 3011373243
In short: On November 21, 2024, FDA issued a Form 483 with 4 observations to Zochem LLC in Dickson, Tennessee (FEI 3011373243) after an inspection that ran Nov 18 – Nov 21, 2024. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Your firm’s laboratory control records for your Zinc Oxide API quality lab tests failed to adequately…
- 03
Appropriate controls are note established over computerized systems in…
- 04
*REPEAT OBSERVATION API product reserve samples are not always stored in the same immediate container-closure…
This inspection in context
Questions about this 483
What did FDA find at Zochem LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Zochem LLC inspected by FDA?
The inspection ran Nov 18 – Nov 21, 2024, and the Form 483 is dated November 21, 2024.
How do I get the full Form 483 for Zochem LLC?
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.