Alembic Pharmaceuticals Limited
Form 483 issued March 20, 2018 · Tajpura, India
- Inspection
- Mar 12 – Mar 20, 2018
- Investigator
- Jessica L. Pressley
- Observations
- 1
- Pages
- 6
- FEI number
- 3004956904
In short: On March 20, 2018, FDA issued a Form 483 with 1 observation to Alembic Pharmaceuticals Limited in Tajpura, India (FEI 3004956904) after an inspection that ran Mar 12 – Mar 20, 2018. The investigator was Jessica L. Pressley. 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×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Jessica L. Pressley
24 documents · 2014–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmAlembic Pharmaceuticals 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alembic Pharmaceuticals 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 Alembic Pharmaceuticals Limited?
Jessica L. Pressley is named on this Form 483, for the inspection of Mar 12 – Mar 20, 2018. Each investigator has a profile showing what they cite most.
When was Alembic Pharmaceuticals Limited inspected by FDA?
The inspection ran Mar 12 – Mar 20, 2018, and the Form 483 is dated March 20, 2018.
How do I get the full Form 483 for Alembic Pharmaceuticals 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.