Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park
Form 483 issued September 6, 2019 · Jadcherla, India
- Inspection
- Aug 29 – Sep 6, 2019
- Investigator
- Roger F. Zabinski
- Observations
- 2
- Pages
- 3
- FEI number
- 3009876430
In short: On September 6, 2019, FDA issued a Form 483 with 2 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 Aug 29 – Sep 6, 2019. The investigator was Roger F. Zabinski. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166(a) (1×) · 211.160(b)(4) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The written stability testing…
- 02
The use of instruments and apparatus not meeting…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 211.166(a)
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 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). 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?
Roger F. Zabinski is named on this Form 483, for the inspection of Aug 29 – Sep 6, 2019. 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 Aug 29 – Sep 6, 2019, and the Form 483 is dated September 6, 2019.
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.