Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park
Form 483 issued November 21, 2025 · Polepally, Jadcherla, India
- Inspection
- Nov 10 – Nov 21, 2025
- Investigators
- Joseph A. Piechocki· Sandra A. Boyd· Youkeun Kim
- Observations
- 8
- Pages
- 24
- FEI number
- 3009876430
In short: On November 21, 2025, FDA issued a Form 483 with 8 observations to Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park in Polepally, Jadcherla, Telangana (FEI 3009876430) after an inspection that ran Nov 10 – Nov 21, 2025. The investigators were Joseph A. Piechocki, Sandra A. Boyd and Youkeun Kim. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.160 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 04
The separate or defined areas and control systems necessary to prevent contamination…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) 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 211.160
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 8 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.160 (general requirements). 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?
Joseph A. Piechocki, Sandra A. Boyd and Youkeun Kim are named on this Form 483, for the inspection of Nov 10 – Nov 21, 2025. 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 Nov 10 – Nov 21, 2025, and the Form 483 is dated November 21, 2025.
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.