Kreative Organics Private Limited
Form 483 issued May 2, 2025 · Jeedimetla, India
- Inspection
- Apr 28 – May 2, 2025
- Investigator
- Saleem A. Akhtar
- Observations
- 3
- Pages
- 3
- FEI number
- 3003447972
In short: On May 2, 2025, FDA issued a Form 483 with 3 observations to Kreative Organics Private Limited in Jeedimetla, Telangana (FEI 3003447972) after an inspection that ran Apr 28 – May 2, 2025. The investigator was Saleem A. Akhtar. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Water used to manufacture APIs and Intermediates is not…
- 02
Validation of the cleaning method used for Sse is deficient. used to cst…
- 03
Product recall procedure was not followed when commercial batch failed during long-term stability testing. i ly…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmKreative Organics Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kreative Organics Private Limited?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Kreative Organics Private Limited?
Saleem A. Akhtar is named on this Form 483, for the inspection of Apr 28 – May 2, 2025. Each investigator has a profile showing what they cite most.
When was Kreative Organics Private Limited inspected by FDA?
The inspection ran Apr 28 – May 2, 2025, and the Form 483 is dated May 2, 2025.
How do I get the full Form 483 for Kreative Organics 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.