Shilpa Medicare Limited Deosugur Industrial Area, Deosugur
Form 483 issued January 19, 2018 · Raichur, India
- Inspection
- Jan 16 – Jan 19, 2018
- Investigator
- June P. Page
- Observations
- 1
- Pages
- 3
- FEI number
- 3007197995
In short: On January 19, 2018, FDA issued a Form 483 with 1 observation to Shilpa Medicare Limited Deosugur Industrial Area, Deosugur in Raichur, India (FEI 3007197995) after an inspection that ran Jan 16 – Jan 19, 2018. The investigator was June P. Page. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern 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
Equipment and utensils are not cleaned and maintained to prevent contamination that would alter the safety…
This inspection in context
June P. Page
30 documents · 2015–2025
Cites 211.42 (design and construction features) 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 211.67
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 1 observation 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 Deosugur Industrial Area, Deosugur?
June P. Page is named on this Form 483, for the inspection of Jan 16 – Jan 19, 2018. 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 Jan 16 – Jan 19, 2018, and the Form 483 is dated January 19, 2018.
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.