Cipla Ltmited
Form 483 issued April 4, 2024 · Raigad, India
- Inspection
- Mar 28 – Apr 4, 2024
- Investigators
- Lori M. Newman· Sean R. Marcsisin
- Observations
- 6
- Pages
- 5
- FEI number
- 3002806710
In short: On April 4, 2024, FDA issued a Form 483 with 6 observations to Cipla Ltmited in Raigad, Maharashtra (FEI 3002806710) after an inspection that ran Mar 28 – Apr 4, 2024. The investigators were Lori M. Newman and Sean R. Marcsisin. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 211.67 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to clean and maintain equipment and utensils to prevent contamination or carry-over of a material…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 03
Failure to adequately investigate…
- 04
Equipment qualification procedures are…
This inspection in context
Lori M. Newman
18 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmCipla Ltmited 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 Cipla Ltmited?
FDA listed 6 observations on this Form 483, mostly about quality system and 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 Cipla Ltmited?
Lori M. Newman and Sean R. Marcsisin are named on this Form 483, for the inspection of Mar 28 – Apr 4, 2024. Each investigator has a profile showing what they cite most.
When was Cipla Ltmited inspected by FDA?
The inspection ran Mar 28 – Apr 4, 2024, and the Form 483 is dated April 4, 2024.
How do I get the full Form 483 for Cipla Ltmited?
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.