Sentiss Pharma Pvt. Ltd.
Form 483 issued May 23, 2017 · District Solan, India
- Inspection
- May 15 – May 23, 2017
- Investigators
- Eileen A. Liu· Sandra A. Hughes
- Observations
- 1
- Pages
- 11
- FEI number
- 3008250236
In short: On May 23, 2017, FDA issued a Form 483 with 1 observation to Sentiss Pharma Pvt. Ltd. in District Solan, India (FEI 3008250236) after an inspection that ran May 15 – May 23, 2017. The investigators were Eileen A. Liu and Sandra A. Hughes. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy did not extend to other drug products that may have been…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmSentiss Pharma Pvt. Ltd. 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 Sentiss Pharma Pvt. Ltd.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sentiss Pharma Pvt. Ltd.?
Eileen A. Liu and Sandra A. Hughes are named on this Form 483, for the inspection of May 15 – May 23, 2017. Each investigator has a profile showing what they cite most.
When was Sentiss Pharma Pvt. Ltd. inspected by FDA?
The inspection ran May 15 – May 23, 2017, and the Form 483 is dated May 23, 2017.
How do I get the full Form 483 for Sentiss Pharma 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.