Kilitch Healthcare India Limited
FDA inspection history in Navi Mumbai, India, 2023 to 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2023: one Form 483; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24One Form 483 and one warning letter, at Navi Mumbai, India.
Cited most
Across all Kilitch Healthcare India Limited observations on file
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.160(a)General requirements2
- 21 CFR 211.42(c)(10)(iv)Design and construction features2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.166(a)(3)Stability testing1
The complete Kilitch Healthcare India Limited file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Navi Mumbai, India
One warning letter and one Form 483 · 2023 to 2024 · 14 observations
Latest: Warning letter, Mar 28, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-28 | Warning letter Warning letter | Navi Mumbai, India | — | $99 |
| 2023-10-20 | 483 Form 483 | Navi Mumbai, India | 14 | $99 |
Investigators on these documents
FEI number 3011853060 · most recent document Mar 28, 2024
About Kilitch Healthcare India Limited
How many FDA Form 483s has Kilitch Healthcare India Limited received?
FDA Intel has 1 Form 483 on file for Kilitch Healthcare India Limited; the most recent is dated Oct 20, 2023.
When was Kilitch Healthcare India Limited last inspected by FDA?
The most recent FDA inspection document on file for Kilitch Healthcare India Limited is a Form 483 dated Oct 20, 2023, for the site in Navi Mumbai, India.
What did FDA cite at Kilitch Healthcare India Limited?
The regulations cited most in the observations on file for Kilitch Healthcare India Limited are 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.160(a) (General requirements), 2 times; 21 CFR 211.42(c)(10)(iv) (Design and construction features), 2 times.
Has Kilitch Healthcare India Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Kilitch Healthcare India Limited; the most recent is dated Mar 28, 2024.