Alembic Pharmaceuticals Limited
Form 483 issued March 13, 2020 · India
- Observations
- 4
- Pages
- 1
- FEI number
- 3004956904
In short: On March 13, 2020, FDA issued a Form 483 with 4 observations to Alembic Pharmaceuticals Limited in Gujarat (FEI 3004956904). Most observations concern quality system and packaging & labeling.
At a glance
Observations span 4 systems, led by quality system.
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…
- 02
Access to the storage area for labels and labeling materials is not…
- 03
Gowning procedures are not applied on a consistent basis: a) CSO Jim entered manufacturing area without…
- 04
Camera equipment that has been implemented to check the Pe ot number printing on the bottom…
This inspection in context
Questions about this 483
What did FDA find at Alembic Pharmaceuticals Limited?
FDA listed 4 observations on this Form 483, mostly about quality system, packaging & labeling and production. The opening words of each observation are shown on this page.
When was Alembic Pharmaceuticals Limited inspected by FDA?
This Form 483 is dated March 13, 2020.
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.