Laurus Synthesis Private Limited
Form 483 issued December 12, 2023 · Anakapalli, India
- Inspection
- Dec 4 – Dec 12, 2023
- Investigators
- Joseph A. Piechocki· Rafeeq Habeeb
- Observations
- 1
- Pages
- 5
- FEI number
- 3010722058
In short: On December 12, 2023, FDA issued a Form 483 with 1 observation to Laurus Synthesis Private Limited in Anakapalli, India (FEI 3010722058) after an inspection that ran Dec 4 – Dec 12, 2023. The investigators were Joseph A. Piechocki and Rafeeq Habeeb. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigation of unexpected occurrences…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLaurus Synthesis Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Laurus Synthesis Private Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Laurus Synthesis Private Limited?
Joseph A. Piechocki and Rafeeq Habeeb are named on this Form 483, for the inspection of Dec 4 – Dec 12, 2023. Each investigator has a profile showing what they cite most.
When was Laurus Synthesis Private Limited inspected by FDA?
The inspection ran Dec 4 – Dec 12, 2023, and the Form 483 is dated December 12, 2023.
How do I get the full Form 483 for Laurus Synthesis 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.