Galaxy Surfactants Limited
Form 483 issued March 30, 2018 · Tarapur, India
- Inspection
- Mar 26 – Mar 30, 2018
- Investigator
- Rajiv R. Srivastava
- Observations
- 2
- Pages
- 3
- FEI number
- 3004879807
In short: On March 30, 2018, FDA issued a Form 483 with 2 observations to Galaxy Surfactants Limited in Tarapur, India (FEI 3004879807) after an inspection that ran Mar 26 – Mar 30, 2018. The investigator was Rajiv R. Srivastava. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Your firm failed to (adequately) validate the analytical method for stability studies of API, to support…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmGalaxy Surfactants Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Galaxy Surfactants Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Galaxy Surfactants Limited?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Mar 26 – Mar 30, 2018. Each investigator has a profile showing what they cite most.
When was Galaxy Surfactants Limited inspected by FDA?
The inspection ran Mar 26 – Mar 30, 2018, and the Form 483 is dated March 30, 2018.
How do I get the full Form 483 for Galaxy Surfactants 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.