Steril-Gene Life Sciences Private Limited
Form 483 issued December 10, 2019 · Puducherry, India
- Inspection
- Dec 2 – Dec 10, 2019
- Investigator
- Jose Velez
- Observations
- 2
- Pages
- 3
- FEI number
- 3014319211
In short: On December 10, 2019, FDA issued a Form 483 with 2 observations to Steril-Gene Life Sciences Private Limited in Puducherry, India (FEI 3014319211) after an inspection that ran Dec 2 – Dec 10, 2019. The investigator was Jose Velez. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.100(b) (1×) · 211.67(b)(6) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production…
- 02
Manufacturer Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmSteril-Gene Life Sciences Private Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Steril-Gene Life Sciences Private Limited?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Steril-Gene Life Sciences Private Limited?
Jose Velez is named on this Form 483, for the inspection of Dec 2 – Dec 10, 2019. Each investigator has a profile showing what they cite most.
When was Steril-Gene Life Sciences Private Limited inspected by FDA?
The inspection ran Dec 2 – Dec 10, 2019, and the Form 483 is dated December 10, 2019.
How do I get the full Form 483 for Steril-Gene Life Sciences 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.