KEKULE PHARMA LIMITED
Form 483 issued March 15, 2024 · Sangareddy District, India
- Inspection
- Mar 15, 2024
- Investigator
- Daniel L. Zheng
- Observations
- 1
- Pages
- 1
- FEI number
- 3009261338
In short: On March 15, 2024, FDA issued a Form 483 with 1 observation to KEKULE PHARMA LIMITED in Sangareddy District, Telangana (FEI 3009261338) after an inspection that ran Mar 15, 2024. The investigator was Daniel L. Zheng. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to document, explain, and investigate any…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmKEKULE PHARMA 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 KEKULE PHARMA LIMITED?
FDA listed 1 observation on this Form 483, mostly about quality system. 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 KEKULE PHARMA LIMITED?
Daniel L. Zheng is named on this Form 483, for the inspection of Mar 15, 2024. Each investigator has a profile showing what they cite most.
When was KEKULE PHARMA LIMITED inspected by FDA?
The inspection ran Mar 15, 2024, and the Form 483 is dated March 15, 2024.
How do I get the full Form 483 for KEKULE PHARMA 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.