Keshava Organics Private Limited
Form 483 issued January 13, 2023 · Palghar, India
- Observations
- 1
- Pages
- 2
- FEI number
- 3003677831
In short: On January 13, 2023, FDA issued a Form 483 with 1 observation to Keshava Organics Private Limited in Palghar, Maharashtra (FEI 3003677831). Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Questions about this 483
What did FDA find at Keshava Organics Private Limited?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Keshava Organics Private Limited inspected by FDA?
This Form 483 is dated January 13, 2023.
How do I get the full Form 483 for Keshava Organics Private Limited?
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