LAURUS SYNTHESIS PRIVATE LIMITED
Form 483 issued December 12, 2023 · Anakapalli, India
- Investigator
- Revers Joseph A. Piechocki
- Observations
- 5
- Pages
- 5
- FEI number
- 3011524794
In short: On December 12, 2023, FDA issued a Form 483 with 5 observations to LAURUS SYNTHESIS PRIVATE LIMITED in Anakapalli, Andhra Pradesh (FEI 3011524794). The investigator was Revers Joseph A. Piechocki. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.188 (2×)
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…
- 02
Sampling plans for intermediates…
- 03
Equipment is not maintained, cleaned, and stored in a…
- 04
Batch production records do not contain complete information related to the production and…
This inspection in context
Revers Joseph A. Piechocki
1 document · 2023
Cites 211.188 (batch production and control records) 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 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LAURUS SYNTHESIS PRIVATE LIMITED?
FDA listed 5 observations on this Form 483, mostly about production, quality system and laboratory controls. 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 LAURUS SYNTHESIS PRIVATE LIMITED?
Revers Joseph A. Piechocki is named on this Form 483. Each investigator has a profile showing what they cite most.
When was LAURUS SYNTHESIS PRIVATE LIMITED inspected by FDA?
This 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.