Zen Chemicals Private Limited
Form 483 issued March 28, 2023 · Dombivili, India
- Inspection
- Mar 23 – Mar 28, 2023
- Observations
- 5
- Pages
- 7
- FEI number
- 3015345351
In short: On March 28, 2023, FDA issued a Form 483 with 5 observations to Zen Chemicals Private Limited in Dombivili, Jalna (FEI 3015345351) after an inspection that ran Mar 23 – Mar 28, 2023. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment are not cleaned and sanitized to prevent contamination of the…
- 02
No investigations are conducted to evaluate all potential root causes…
- 03
Appropriate controls governing computer acquired data and/or related systems have not been established to assure that…
- 04
Qualification of equipment were…
This inspection in context
Questions about this 483
What did FDA find at Zen Chemicals Private Limited?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and quality system. 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 Zen Chemicals Private Limited inspected by FDA?
The inspection ran Mar 23 – Mar 28, 2023, and the Form 483 is dated March 28, 2023.
How do I get the full Form 483 for Zen Chemicals Private Limited?
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.