Encube Ethicals Private Limited
Form 483 issued June 11, 2019 · Ponda, India
- Inspection
- Jun 4 – Jun 11, 2019
- Investigator
- Kellia N. Hicks
- Observations
- 7
- Pages
- 8
- FEI number
- 3005669319
In short: On June 11, 2019, FDA issued a Form 483 with 7 observations to Encube Ethicals Private Limited in Ponda, India (FEI 3005669319) after an inspection that ran Jun 4 – Jun 11, 2019. The investigator was Kellia N. Hicks. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Established laboratory control mechanisms are not followed and documented at…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
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 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Encube Ethicals Private Limited?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Encube Ethicals Private Limited?
Kellia N. Hicks is named on this Form 483, for the inspection of Jun 4 – Jun 11, 2019. Each investigator has a profile showing what they cite most.
When was Encube Ethicals Private Limited inspected by FDA?
The inspection ran Jun 4 – Jun 11, 2019, and the Form 483 is dated June 11, 2019.
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.