Wizcure Pharmaa Private Limited
Form 483 issued December 3, 2012 · Bhiwadi, India
- Inspection
- Dec 3 – Dec 10, 2025
- Investigators
- Lisa L. Flores· Robert J. Ham
- Observations
- 6
- Pages
- 19
- FEI number
- 3030304532
In short: On December 3, 2012, FDA issued a Form 483 with 6 observations to Wizcure Pharmaa Private Limited in Bhiwadi, India (FEI 3030304532) after an inspection that ran Dec 3 – Dec 10, 2025. The investigators were Lisa L. Flores and Robert J. Ham. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 05
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. A. Personnel monitoring program…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmWizcure Pharmaa Private 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wizcure Pharmaa Private Limited?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Wizcure Pharmaa Private Limited?
Lisa L. Flores and Robert J. Ham are named on this Form 483, for the inspection of Dec 3 – Dec 10, 2025. Each investigator has a profile showing what they cite most.
When was Wizcure Pharmaa Private Limited inspected by FDA?
The inspection ran Dec 3 – Dec 10, 2025, and the Form 483 is dated December 3, 2012.
How do I get the full Form 483 for Wizcure Pharmaa Private 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.