Synergene Active Ingredients Private Limited
Form 483 issued February 17, 2024 · Anakapalli, India
- Inspection
- Feb 13 – Feb 17, 2024
- Investigator
- Dipesh K. Shah
- Observations
- 3
- Pages
- 3
- FEI number
- 3010634351
In short: On February 17, 2024, FDA issued a Form 483 with 3 observations to Synergene Active Ingredients Private Limited in Anakapalli, Andhra Pradesh (FEI 3010634351) after an inspection that ran Feb 13 – Feb 17, 2024. The investigator was Dipesh K. Shah. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigation have not been…
- 02
Equipment are not cleaned and sanitized to…
- 03
The documentation of your process…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSynergene Active Ingredients 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 Synergene Active Ingredients Private Limited?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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 Synergene Active Ingredients Private Limited?
Dipesh K. Shah is named on this Form 483, for the inspection of Feb 13 – Feb 17, 2024. Each investigator has a profile showing what they cite most.
When was Synergene Active Ingredients Private Limited inspected by FDA?
The inspection ran Feb 13 – Feb 17, 2024, and the Form 483 is dated February 17, 2024.
How do I get the full Form 483 for Synergene Active Ingredients Private Limited?
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