Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park
Form 483 issued November 9, 2023 · Jadcherla, India
- Inspection
- Oct 30 – Nov 9, 2023
- Investigators
- Eileen A. Liu· Rajiv R. Srivastava
- Observations
- 10
- Pages
- 14
- FEI number
- 3009876430
In short: On November 9, 2023, FDA issued a Form 483 with 10 observations to Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park in Jadcherla, Telangana (FEI 3009876430) after an inspection that ran Oct 30 – Nov 9, 2023. The investigators were Eileen A. Liu and Rajiv R. Srivastava. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to test samples of each component for conformity with all appropriate written specifications…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Procedure designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
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 firmShilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park?
Eileen A. Liu and Rajiv R. Srivastava are named on this Form 483, for the inspection of Oct 30 – Nov 9, 2023. Each investigator has a profile showing what they cite most.
When was Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park inspected by FDA?
The inspection ran Oct 30 – Nov 9, 2023, and the Form 483 is dated November 9, 2023.
How do I get the full Form 483 for Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park?
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.