Cohance Lifesciences Limited
Form 483 issued August 12, 2025 · Secunderabad, India
- Inspection
- Aug 4 – Aug 12, 2025
- Investigator
- Guerlain Ulysse
- Observations
- 6
- Pages
- 17
- FEI number
- 3008768274
In short: On August 12, 2025, FDA issued a Form 483 with 6 observations to Cohance Lifesciences Limited in Secunderabad, India (FEI 3008768274) after an inspection that ran Aug 4 – Aug 12, 2025. The investigator was Guerlain Ulysse. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written records of investigation of a diug complaint do…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCohance Lifesciences Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cohance Lifesciences Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Cohance Lifesciences Limited?
Guerlain Ulysse is named on this Form 483, for the inspection of Aug 4 – Aug 12, 2025. Each investigator has a profile showing what they cite most.
When was Cohance Lifesciences Limited inspected by FDA?
The inspection ran Aug 4 – Aug 12, 2025, and the Form 483 is dated August 12, 2025.
How do I get the full Form 483 for Cohance Lifesciences 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.