Ocean Healthcare Pvt Ltd
Form 483 issued June 14, 2024 · Chengulpet, India
- Inspection
- Jun 10 – Jun 14, 2024
- Investigator
- Truong X. Nguyen
- Observations
- 3
- Pages
- 2
- FEI number
- 3015621300
In short: On June 14, 2024, FDA issued a Form 483 with 3 observations to Ocean Healthcare Pvt Ltd in Chengulpet, Tamil Nadu (FEI 3015621300) after an inspection that ran Jun 10 – Jun 14, 2024. The investigator was Truong X. Nguyen. Most observations concern quality system and materials.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures describing the handling of complaints do not include provisions for explaining the reasons for…
- 02
Each component is not tested for conformity with all appropriate written specifications for…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmOcean Healthcare Pvt Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ocean Healthcare Pvt Ltd?
FDA listed 3 observations on this Form 483, mostly about quality system and materials. The opening words of each observation are shown on this page.
Who inspected Ocean Healthcare Pvt Ltd?
Truong X. Nguyen is named on this Form 483, for the inspection of Jun 10 – Jun 14, 2024. Each investigator has a profile showing what they cite most.
When was Ocean Healthcare Pvt Ltd inspected by FDA?
The inspection ran Jun 10 – Jun 14, 2024, and the Form 483 is dated June 14, 2024.
How do I get the full Form 483 for Ocean Healthcare 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.