ABRYL LABORATORIES PRIVATE LIMITED
Form 483 issued January 22, 2022 · SAS NAGAR, India
- Inspection
- Jan 13 – Jan 22, 2022
- Investigator
- Rita K. Kabaso
- Observations
- 9
- Pages
- 12
- FEI number
- 3015793804
In short: On January 22, 2022, FDA issued a Form 483 with 9 observations to ABRYL LABORATORIES PRIVATE LIMITED in SAS NAGAR, Punjab (FEI 3015793804) after an inspection that ran Jan 13 – Jan 22, 2022. The investigator was Rita K. Kabaso. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 6 of 9 observations.
Most cited: 21 CFR 211.42 (2×)
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 did not include…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Rita K. Kabaso
18 documents · 2015–2023
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ABRYL LABORATORIES PRIVATE LIMITED?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected ABRYL LABORATORIES PRIVATE LIMITED?
Rita K. Kabaso is named on this Form 483, for the inspection of Jan 13 – Jan 22, 2022. Each investigator has a profile showing what they cite most.
When was ABRYL LABORATORIES PRIVATE LIMITED inspected by FDA?
The inspection ran Jan 13 – Jan 22, 2022, and the Form 483 is dated January 22, 2022.
How do I get the full Form 483 for ABRYL LABORATORIES PRIVATE LIMITED?
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