Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park
Form 483 issued November 30, 2017 · Polepally, India
- Inspection
- Nov 20 – Nov 30, 2017
- Investigator
- Sandra A. Hughes
- Observations
- 3
- Pages
- 6
- FEI number
- 3009876430
In short: On November 30, 2017, FDA issued a Form 483 with 3 observations to Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park in Polepally, India (FEI 3009876430) after an inspection that ran Nov 20 – Nov 30, 2017. The investigator was Sandra A. Hughes. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
g/vial is labeled with…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient…
This inspection in context
Sandra A. Hughes
23 documents · 2009–2019
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Wisconsin.
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 211.67
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 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). 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?
Sandra A. Hughes is named on this Form 483, for the inspection of Nov 20 – Nov 30, 2017. 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 20 – Nov 30, 2017, and the Form 483 is dated November 30, 2017.
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.