Alembic Pharmaceuticals Limited
Form 483 issued March 25, 2016 · Dist. Panchmahal, India
- Inspection
- Mar 21 – Mar 25, 2016
- Investigators
- Erika V. Butler· Jason K. Morgan· Zhaoyang Meng
- Observations
- 1
- Pages
- 4
- FEI number
- 3004956904
In short: On March 25, 2016, FDA issued a Form 483 with 1 observation to Alembic Pharmaceuticals Limited in Dist. Panchmahal, India (FEI 3004956904) after an inspection that ran Mar 21 – Mar 25, 2016. The investigators were Erika V. Butler, Jason K. Morgan and Zhaoyang Meng. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
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 211.22
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 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Alembic Pharmaceuticals Limited?
Erika V. Butler, Jason K. Morgan and Zhaoyang Meng are named on this Form 483, for the inspection of Mar 21 – Mar 25, 2016. Each investigator has a profile showing what they cite most.
When was Alembic Pharmaceuticals Limited inspected by FDA?
The inspection ran Mar 21 – Mar 25, 2016, and the Form 483 is dated March 25, 2016.
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.