Encube Ethicals Private Limited
Form 483 issued June 17, 2024 · Ponda, India
- Inspection
- Jun 11 – Jun 17, 2024
- Investigator
- Yvins Dezan
- Observations
- 9
- Pages
- 12
- FEI number
- 3005669319
In short: On June 17, 2024, FDA issued a Form 483 with 9 observations to Encube Ethicals Private Limited in Ponda, India (FEI 3005669319) after an inspection that ran Jun 11 – Jun 17, 2024. The investigator was Yvins Dezan. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
- 04
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained…
This inspection in context
Yvins Dezan
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmEncube Ethicals Private Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Encube Ethicals Private Limited?
FDA listed 9 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Encube Ethicals Private Limited?
Yvins Dezan is named on this Form 483, for the inspection of Jun 11 – Jun 17, 2024. Each investigator has a profile showing what they cite most.
When was Encube Ethicals Private Limited inspected by FDA?
The inspection ran Jun 11 – Jun 17, 2024, and the Form 483 is dated June 17, 2024.
How do I get the full Form 483 for Encube Ethicals 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.