ABRYL LABORATORIES PRIVATE LIMITED
Form 483 issued November 20, 2023 · SAS NAGAR, India
- Inspection
- Nov 14 – Nov 20, 2023
- Investigator
- Kellia N. Hicks
- Observations
- 5
- Pages
- 5
- FEI number
- 3015793804
In short: On November 20, 2023, FDA issued a Form 483 with 5 observations to ABRYL LABORATORIES PRIVATE LIMITED in SAS NAGAR, Punjab (FEI 3015793804) after an inspection that ran Nov 14 – Nov 20, 2023. The investigator was Kellia N. Hicks. Most observations concern quality system and laboratory controls.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records are deficient in that they do not include a complete record of all data…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ABRYL LABORATORIES PRIVATE LIMITED?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected ABRYL LABORATORIES PRIVATE LIMITED?
Kellia N. Hicks is named on this Form 483, for the inspection of Nov 14 – Nov 20, 2023. Each investigator has a profile showing what they cite most.
When was ABRYL LABORATORIES PRIVATE LIMITED inspected by FDA?
The inspection ran Nov 14 – Nov 20, 2023, and the Form 483 is dated November 20, 2023.
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.