Alkem Laboratories Ltd
Form 483 issued May 1, 2026 · Daman and Diu, India
- Inspection
- Apr 20 – May 1, 2026
- Investigators
- Pratik S. Upadhyay· Unnee Ranjan
- Observations
- 7
- Pages
- 26
- FEI number
- 3006370524
In short: On May 1, 2026, FDA issued a Form 483 with 7 observations to Alkem Laboratories Ltd in Daman and Diu, India (FEI 3006370524) after an inspection that ran Apr 20 – May 1, 2026. The investigators were Pratik S. Upadhyay and Unnee Ranjan. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.192 (2×) · 211.100 (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
The responsibilities and procedures applicable to the quality control unit…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Your examination and testing of samples did not assure that the drug product and in-process…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAlkem Laboratories Ltd history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alkem Laboratories Ltd?
FDA listed 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. 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 Alkem Laboratories Ltd?
Pratik S. Upadhyay and Unnee Ranjan are named on this Form 483, for the inspection of Apr 20 – May 1, 2026. Each investigator has a profile showing what they cite most.
When was Alkem Laboratories Ltd inspected by FDA?
The inspection ran Apr 20 – May 1, 2026, and the Form 483 is dated May 1, 2026.
How do I get the full Form 483 for Alkem Laboratories Ltd?
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.