Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar
Form 483 issued November 13, 2024 · Bengaluru, India
- Inspection
- Nov 7 – Nov 13, 2024
- Investigators
- Guerlain Ulysse· Kellia N. Hicks
- Observations
- 8
- Pages
- 11
- FEI number
- 3002806691
In short: On November 13, 2024, FDA issued a Form 483 with 8 observations to Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar in Bengaluru, Karnataka (FEI 3002806691) after an inspection that ran Nov 7 – Nov 13, 2024. The investigators were Guerlain Ulysse and Kellia N. Hicks. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 5 of 8 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Repeat Observation Equipment used to control and monitor critical process parameters identified in the manufacture of…
- 02
Clear instructions and controls are not established and implemented to ensure that critical process parameters (CPPs)…
- 03
Current manufacturing practices do not ensure that operators are present and actively monitoring critical process parameters…
- 04
Appropriate line clearance checks are not conducted to ensure that materials are removed, and equipment is…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar?
FDA listed 8 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar?
Guerlain Ulysse and Kellia N. Hicks are named on this Form 483, for the inspection of Nov 7 – Nov 13, 2024. Each investigator has a profile showing what they cite most.
When was Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar inspected by FDA?
The inspection ran Nov 7 – Nov 13, 2024, and the Form 483 is dated November 13, 2024.
How do I get the full Form 483 for Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar?
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.