SRIKEM LABORATORIES PRIVATE LIMITED
Form 483 issued May 31, 2024 · Navi Mumbai, India
- Investigators
- Arsen Karapetyan· Ee Ls By· Ftepchyor Arsen Karapetyan
- Observations
- 11
- Pages
- 12
- FEI number
- 3005048741
In short: On May 31, 2024, FDA issued a Form 483 with 11 observations to SRIKEM LABORATORIES PRIVATE LIMITED in Navi Mumbai, Maharashtra (FEI 3005048741). The investigators were Arsen Karapetyan, Ee Ls By, Ftepchyor Arsen Karapetyan and Wayne D. McGrath. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and production account for 7 of 11 observations.
Most cited: 21 CFR 211.100 (2×) · 211.180 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Documents related to the manufacture of intermediates or active pharmaceutical ingredients (APIs) are not prepared, reviewed…
- 02
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 03
Laboratory control procedures are…
- 04
Batch manufacturing activities are not always documented at the…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmSRIKEM LABORATORIES PRIVATE 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SRIKEM LABORATORIES PRIVATE LIMITED?
FDA listed 11 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected SRIKEM LABORATORIES PRIVATE LIMITED?
Arsen Karapetyan, Ee Ls By, Ftepchyor Arsen Karapetyan and Wayne D. McGrath are named on this Form 483. Each investigator has a profile showing what they cite most.
When was SRIKEM LABORATORIES PRIVATE LIMITED inspected by FDA?
This Form 483 is dated May 31, 2024.
How do I get the full Form 483 for SRIKEM LABORATORIES PRIVATE 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.