Zydus Lifesciences Limited
Form 483 issued May 3, 2019 · Ahmedabad, India
- Inspection
- Apr 22 – May 3, 2019
- Investigators
- Justin A. Boyd· Rita K. Kabaso· Thomas J. Arista
- Observations
- 14
- Pages
- 23
- FEI number
- 3002984011
In short: On May 3, 2019, FDA issued a Form 483 with 14 observations to Zydus Lifesciences Limited in Ahmedabad, Gujarat (FEI 3002984011) after an inspection that ran Apr 22 – May 3, 2019. The investigators were Justin A. Boyd, Rita K. Kabaso and Thomas J. Arista. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 11 of 14 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned an d maintained at appropriate intervals to prevent contamination that…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmZydus Lifesciences Limited history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zydus Lifesciences Limited?
FDA listed 14 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 Zydus Lifesciences Limited?
Justin A. Boyd, Rita K. Kabaso and Thomas J. Arista are named on this Form 483, for the inspection of Apr 22 – May 3, 2019. Each investigator has a profile showing what they cite most.
When was Zydus Lifesciences Limited inspected by FDA?
The inspection ran Apr 22 – May 3, 2019, and the Form 483 is dated May 3, 2019.
How do I get the full Form 483 for Zydus Lifesciences 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.