LS Promotions Inc
Form 483 issued May 2, 2024 · Ronkonkoma, New York
- Inspection
- Apr 24 – May 2, 2024
- Investigators
- Adena S. Yau· Amatul H. Marium· Raihan A. Chowdhury
- Observations
- 11
- Pages
- 7
- FEI number
- 3002657228
In short: On May 2, 2024, FDA issued a Form 483 with 11 observations to LS Promotions Inc in Ronkonkoma, New York (FEI 3002657228) after an inspection that ran Apr 24 – May 2, 2024. The investigators were Adena S. Yau, Amatul H. Marium and Raihan A. Chowdhury. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and materials account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
There is no written testing program designed to assess the stability…
- 04
Routine calibration, inspection and checking of automatic equipment is not performed according to a written progr…
This inspection in context
Adena S. Yau
1 document · 2024
Cites 211.188(b)(6) (batch production and control records) more than any other section. Most of their documents are for sites in New York.
The firmLS Promotions Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LS Promotions Inc?
FDA listed 11 observations on this Form 483, mostly about production, materials and quality system. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected LS Promotions Inc?
Adena S. Yau, Amatul H. Marium and Raihan A. Chowdhury are named on this Form 483, for the inspection of Apr 24 – May 2, 2024. Each investigator has a profile showing what they cite most.
When was LS Promotions Inc inspected by FDA?
The inspection ran Apr 24 – May 2, 2024, and the Form 483 is dated May 2, 2024.
How do I get the full Form 483 for LS Promotions Inc?
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.