Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar
Form 483 issued July 19, 2019 · Bengaluru, India
- Inspection
- Jul 15 – Jul 19, 2019
- Investigators
- Christopher Keating· Ralph H. Vocque
- Observations
- 7
- Pages
- 6
- FEI number
- 3002806691
In short: On July 19, 2019, FDA issued a Form 483 with 7 observations to Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar in Bengaluru, Karnataka (FEI 3002806691) after an inspection that ran Jul 15 – Jul 19, 2019. The investigators were Christopher Keating and Ralph H. Vocque. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Observations span 4 systems, led by quality system.
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
Investigations into out-of-specification (OOS) QC analytical results, related to finished AP! product quality…
- 02
Equipment used to control and monitor critical process parameters identified in the manufacture of APIs and…
- 03
Preventative controls over your electronic inventory and warehousing management systems are not effectively established to prevent…
- 04
Process validations of API intermediates are not designed and executed in a manner consistent with the…
This inspection in context
Christopher Keating
13 documents · 2018–2020
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 7 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Cipla, Ltd - Virgonagar Site Old Madras Road, Virgonagar?
Christopher Keating and Ralph H. Vocque are named on this Form 483, for the inspection of Jul 15 – Jul 19, 2019. 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 Jul 15 – Jul 19, 2019, and the Form 483 is dated July 19, 2019.
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.