Kilitch Healthcare India Limited
Form 483 issued October 20, 2023 · Navi Mumbai, India
- Inspection
- Oct 12 – Oct 20, 2023
- Investigators
- Anastasia M. Shields· Justin A. Boyd
- Observations
- 14
- Pages
- 19
- FEI number
- 3011853060
In short: On October 20, 2023, FDA issued a Form 483 with 14 observations to Kilitch Healthcare India Limited in Navi Mumbai, Maharashtra (FEI 3011853060) after an inspection that ran Oct 12 – Oct 20, 2023. The investigators were Anastasia M. Shields and Justin A. Boyd. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedm es designed to prevent microbiological contamination of diug products pmporting to be sterile are not…
- 02
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
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmKilitch Healthcare India 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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kilitch Healthcare India Limited?
FDA listed 14 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 Kilitch Healthcare India Limited?
Anastasia M. Shields and Justin A. Boyd are named on this Form 483, for the inspection of Oct 12 – Oct 20, 2023. Each investigator has a profile showing what they cite most.
When was Kilitch Healthcare India Limited inspected by FDA?
The inspection ran Oct 12 – Oct 20, 2023, and the Form 483 is dated October 20, 2023.
How do I get the full Form 483 for Kilitch Healthcare India 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.