ABRYL LABORATORIES PRIVATE LIMITED
Form 483 issued December 6, 2022 · SAS NAGAR, India
- Observations
- 5
- Pages
- 5
- FEI number
- 3015793804
In short: On December 6, 2022, FDA issued a Form 483 with 5 observations to ABRYL LABORATORIES PRIVATE LIMITED in SAS NAGAR, Punjab (FEI 3015793804). Most observations concern production and facilities & equipment.
At a glance
3 of 5 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Questions about this 483
What did FDA find at ABRYL LABORATORIES PRIVATE LIMITED?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
When was ABRYL LABORATORIES PRIVATE LIMITED inspected by FDA?
This Form 483 is dated December 6, 2022.
How do I get the full Form 483 for ABRYL LABORATORIES PRIVATE 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.