Amoli Organics (A Division of Umedica Laboratories Pvt.Ltd.)
Form 483 issued January 12, 2024 · Vadodara, India
- Inspection
- Jan 8 – Jan 12, 2024
- Investigator
- Kham Phommachanh
- Observations
- 1
- Pages
- 1
- FEI number
- 3007836955
In short: On January 12, 2024, FDA issued a Form 483 with 1 observation to Amoli Organics (A Division of Umedica Laboratories Pvt.Ltd.) in Vadodara, Gujarat (FEI 3007836955) after an inspection that ran Jan 8 – Jan 12, 2024. The investigator was Kham Phommachanh. The most-cited regulation is 21 CFR 201.122 (drugs for processing, repacking, or manufacturing).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 201.122
Special legal requirement such as Caution Statement and Rx not included on the label of active…
This inspection in context
Kham Phommachanh
12 documents · 2009–2024
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Canada.
The firmAmoli Organics (A Division of Umedica Laboratories Pvt.Ltd.) history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Amoli Organics (A Division of Umedica Laboratories Pvt.Ltd.)?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 201.122 (drugs for processing, repacking, or manufacturing). The opening words of each observation are shown on this page.
Who inspected Amoli Organics (A Division of Umedica Laboratories Pvt.Ltd.)?
Kham Phommachanh is named on this Form 483, for the inspection of Jan 8 – Jan 12, 2024. Each investigator has a profile showing what they cite most.
When was Amoli Organics (A Division of Umedica Laboratories Pvt.Ltd.) inspected by FDA?
The inspection ran Jan 8 – Jan 12, 2024, and the Form 483 is dated January 12, 2024.
How do I get the full Form 483 for Amoli Organics (A Division of Umedica Laboratories Pvt.Ltd.)?
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.