ABRYL LABORATORIES PRIVATE LIMITED
Form 483 issued August 20, 2024 · SAS NAGAR, India
- Inspection
- Aug 12 – Aug 20, 2024
- Investigators
- Crystal Monroy· Gavin T. Cua
- Observations
- 3
- Pages
- 4
- FEI number
- 3015793804
In short: On August 20, 2024, FDA issued a Form 483 with 3 observations to ABRYL LABORATORIES PRIVATE LIMITED in SAS NAGAR, Punjab (FEI 3015793804) after an inspection that ran Aug 12 – Aug 20, 2024. The investigators were Crystal Monroy and Gavin T. Cua. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Crystal Monroy
15 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmABRYL LABORATORIES PRIVATE LIMITED history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ABRYL LABORATORIES PRIVATE LIMITED?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected ABRYL LABORATORIES PRIVATE LIMITED?
Crystal Monroy and Gavin T. Cua are named on this Form 483, for the inspection of Aug 12 – Aug 20, 2024. Each investigator has a profile showing what they cite most.
When was ABRYL LABORATORIES PRIVATE LIMITED inspected by FDA?
The inspection ran Aug 12 – Aug 20, 2024, and the Form 483 is dated August 20, 2024.
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.