SRIKEM LABORATORIES PRIVATE LIMITED
FDA inspection history in Navi Mumbai, India, 2016 to 2024
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one warning letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One warning letter, at Navi Mumbai, India.
- 2024One Form 483, at Navi Mumbai, India.
Cited most
Across all SRIKEM LABORATORIES PRIVATE LIMITED observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.180General requirements2
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.188Batch production and control records1
The complete SRIKEM LABORATORIES PRIVATE 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 Form 483 and one warning letter · 2016 to 2024
Latest: Form 483, May 31, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-31 | 483 Form 483 | Navi Mumbai, India | — | $99 |
| 2016-11-08 | Warning letter Warning letter | Navi Mumbai, India | — | $99 |
Investigators on these documents
Arsen Karapetyan (1)Ee Ls By (1)Ftepchyor Arsen Karapetyan (1)Wayne D. McGrath (1)
FEI number 3005048741 · most recent document May 31, 2024
About SRIKEM LABORATORIES PRIVATE LIMITED
How many FDA Form 483s has SRIKEM LABORATORIES PRIVATE LIMITED received?
FDA Intel has 1 Form 483 on file for SRIKEM LABORATORIES PRIVATE LIMITED; the most recent is dated May 31, 2024.
When was SRIKEM LABORATORIES PRIVATE LIMITED last inspected by FDA?
The most recent FDA inspection document on file for SRIKEM LABORATORIES PRIVATE LIMITED is a Form 483 dated May 31, 2024, for the site in Navi Mumbai, India.
What did FDA cite at SRIKEM LABORATORIES PRIVATE LIMITED?
The regulations cited most in the observations on file for SRIKEM LABORATORIES PRIVATE LIMITED are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.180 (General requirements), 2 times; 21 CFR 211.160 (General requirements), 1 time.
Has SRIKEM LABORATORIES PRIVATE LIMITED received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for SRIKEM LABORATORIES PRIVATE LIMITED; the most recent is dated Nov 8, 2016.