SOFTGEL HEALTHCARE PRIVATE LIMITED
Form 483 issued February 14, 2025 · Chengalpattu, India
- Inspection
- Feb 10 – Feb 14, 2025
- Investigator
- Arsen Karapetyan
- Observations
- 3
- Pages
- 3
- FEI number
- 3006381009
In short: On February 14, 2025, FDA issued a Form 483 with 3 observations to SOFTGEL HEALTHCARE PRIVATE LIMITED in Chengalpattu, Tamilnadu (FEI 3006381009) after an inspection that ran Feb 10 – Feb 14, 2025. The investigator was Arsen Karapetyan. Most observations concern quality system and facilities & equipment.
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 records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. Investigations…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmSOFTGEL HEALTHCARE 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 SOFTGEL HEALTHCARE PRIVATE LIMITED?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected SOFTGEL HEALTHCARE PRIVATE LIMITED?
Arsen Karapetyan is named on this Form 483, for the inspection of Feb 10 – Feb 14, 2025. Each investigator has a profile showing what they cite most.
When was SOFTGEL HEALTHCARE PRIVATE LIMITED inspected by FDA?
The inspection ran Feb 10 – Feb 14, 2025, and the Form 483 is dated February 14, 2025.
How do I get the full Form 483 for SOFTGEL HEALTHCARE 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.