Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura
Form 483 issued May 31, 2025 · PANCHMAHAL, India
- Inspection
- May 26 – May 31, 2025
- Investigator
- Pratik S. Upadhyay
- Observations
- 4
- Pages
- 7
- FEI number
- 3003821360
In short: On May 31, 2025, FDA issued a Form 483 with 4 observations to Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura in PANCHMAHAL, Gujarat (FEI 3003821360) after an inspection that ran May 26 – May 31, 2025. The investigator was Pratik S. Upadhyay. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
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
Laboratory investigations were not conducted timely based on an identifiable trend or thoroughly to…
- 02
Laboratory control does not include establishment of scientifically sound and appropriate test procedures and specifications designed…
- 03
Equipment is not cleaned and maintained to prevent contamination that would alter the safety, identity, strength…
- 04
Lack of Quality Unit oversight on…
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 firmAlembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura?
Pratik S. Upadhyay is named on this Form 483, for the inspection of May 26 – May 31, 2025. Each investigator has a profile showing what they cite most.
When was Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura inspected by FDA?
The inspection ran May 26 – May 31, 2025, and the Form 483 is dated May 31, 2025.
How do I get the full Form 483 for Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura?
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.