Astral SteriTech Private Limited
Form 483 issued June 20, 2023 · Vadodara, India
- Inspection
- Jun 12 – Jun 20, 2023
- Investigator
- Arlney A. Repo
- Observations
- 4
- Pages
- 8
- FEI number
- 3005508230
In short: On June 20, 2023, FDA issued a Form 483 with 4 observations to Astral SteriTech Private Limited in Vadodara, Gujarat (FEI 3005508230) after an inspection that ran Jun 12 – Jun 20, 2023. The investigator was Arlney A. Repo. 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 3 of 4 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
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Aseptic processing areas are deficient in that floors, walls and ceilings are not smooth and/or hard…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Arlney A. Repo
1 document · 2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmAstral SteriTech Private Limited history
The site's inspection history, in date order.
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 Astral SteriTech Private Limited?
FDA listed 4 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 Astral SteriTech Private Limited?
Arlney A. Repo is named on this Form 483, for the inspection of Jun 12 – Jun 20, 2023. Each investigator has a profile showing what they cite most.
When was Astral SteriTech Private Limited inspected by FDA?
The inspection ran Jun 12 – Jun 20, 2023, and the Form 483 is dated June 20, 2023.
How do I get the full Form 483 for Astral SteriTech 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.