Shilpa Medicare Limited
Form 483 issued February 25, 2020 · Polepally, Jadcherla, India
- Inspection
- Feb 13 – Feb 25, 2020
- Investigators
- Jose E. Melendez· Miguel A. Martinez
- Observations
- 15
- Pages
- 25
- FEI number
- 3009876030
In short: On February 25, 2020, FDA issued a Form 483 with 15 observations to Shilpa Medicare Limited in Polepally, Jadcherla, India (FEI 3009876030) after an inspection that ran Feb 13 – Feb 25, 2020. The investigators were Jose E. Melendez and Miguel A. Martinez. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your Quality Unit failed to ensure that all production and laboratory control operations…
- 02
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmShilpa Medicare Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shilpa Medicare Limited?
FDA listed 15 observations on this Form 483, mostly about laboratory controls, quality system 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?
Jose E. Melendez and Miguel A. Martinez are named on this Form 483, for the inspection of Feb 13 – Feb 25, 2020. Each investigator has a profile showing what they cite most.
When was Shilpa Medicare Limited inspected by FDA?
The inspection ran Feb 13 – Feb 25, 2020, and the Form 483 is dated February 25, 2020.
How do I get the full Form 483 for Shilpa Medicare Limited?
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.