Ocean Healthcare Pvt Ltd
FDA inspection history in Chengulpet, India, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Chengulpet, India.
Cited most
Across all Ocean Healthcare Pvt observations on file
- 21 CFR 211.198(a)Complaint files1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete Ocean Healthcare Pvt file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Chengulpet, India
One Form 483 · 2024 · 3 observations
Latest: Form 483, Jun 14, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-14 | 483 Form 483 | Chengulpet, India | 3 | $99 |
Investigators on these documents
FEI number 3015621300 · most recent document Jun 14, 2024
About Ocean Healthcare Pvt Ltd
How many FDA Form 483s has Ocean Healthcare Pvt Ltd received?
FDA Intel has 1 Form 483 on file for Ocean Healthcare Pvt Ltd; the most recent is dated Jun 14, 2024.
When was Ocean Healthcare Pvt Ltd last inspected by FDA?
The most recent FDA inspection document on file for Ocean Healthcare Pvt Ltd is a Form 483 dated Jun 14, 2024, for the site in Chengulpet, India.
What did FDA cite at Ocean Healthcare Pvt Ltd?
The regulations cited most in the observations on file for Ocean Healthcare Pvt Ltd are 21 CFR 211.198(a) (Complaint files), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time; 21 CFR 211.84(d)(2) (Testing and approval or rejection of components, drug product containers, and closures), 1 time.