Alembic Pharmaceuticals Limited
Form 483 issued December 16, 2022 · Jarod, India
- Inspection
- Dec 8 – Dec 16, 2022
- Observations
- 5
- Pages
- 4
- FEI number
- 3016088083
In short: On December 16, 2022, FDA issued a Form 483 with 5 observations to Alembic Pharmaceuticals Limited in Jarod, Gujarat (FEI 3016088083) after an inspection that ran Dec 8 – Dec 16, 2022. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Facilities & equipment and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, sanitized or maintained at appropriate intervals to prevent malfunctions or…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Questions about this 483
What did FDA find at Alembic Pharmaceuticals Limited?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and 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.
When was Alembic Pharmaceuticals Limited inspected by FDA?
The inspection ran Dec 8 – Dec 16, 2022, and the Form 483 is dated December 16, 2022.
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.