Shilpa Medicare Limited Deosugur Industrial Area, Deosugur
Form 483 issued July 26, 2019 · Raichur, India
- Inspection
- Jul 22 – Jul 26, 2019
- Investigator
- Yvins Dezan
- Observations
- 5
- Pages
- 6
- FEI number
- 3007197995
In short: On July 26, 2019, FDA issued a Form 483 with 5 observations to Shilpa Medicare Limited Deosugur Industrial Area, Deosugur in Raichur, Karnataka (FEI 3007197995) after an inspection that ran Jul 22 – Jul 26, 2019. The investigator was Yvins Dezan. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Equipment used in the manufacture of intermediates and APIs is not…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Yvins Dezan
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmShilpa Medicare Limited Deosugur Industrial Area, Deosugur history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shilpa Medicare Limited Deosugur Industrial Area, Deosugur?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Shilpa Medicare Limited Deosugur Industrial Area, Deosugur?
Yvins Dezan is named on this Form 483, for the inspection of Jul 22 – Jul 26, 2019. Each investigator has a profile showing what they cite most.
When was Shilpa Medicare Limited Deosugur Industrial Area, Deosugur inspected by FDA?
The inspection ran Jul 22 – Jul 26, 2019, and the Form 483 is dated July 26, 2019.
How do I get the full Form 483 for Shilpa Medicare Limited Deosugur Industrial Area, Deosugur?
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.