Yash Pharma Laboratories Pvt Ltd.
Form 483 issued September 3, 2019 · Roorkee, India
- Inspection
- Aug 26 – Sep 3, 2019
- Investigators
- Letitia Robinson· Rajiv R. Srivastava
- Observations
- 8
- Pages
- 8
- FEI number
- 3012020703
In short: On September 3, 2019, FDA issued a Form 483 with 8 observations to Yash Pharma Laboratories Pvt Ltd. in Roorkee, Uttarakhand (FEI 3012020703) after an inspection that ran Aug 26 – Sep 3, 2019. The investigators were Letitia Robinson and Rajiv R. Srivastava. Most observations concern packaging & labeling and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Packaging & labeling and facilities & equipment account for 5 of 8 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 03
OTC products packaged for retail…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Letitia Robinson
1 document · 2019
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in India.
The firmYash Pharma Laboratories Pvt Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Yash Pharma Laboratories Pvt Ltd.?
FDA listed 8 observations on this Form 483, mostly about packaging & labeling, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Yash Pharma Laboratories Pvt Ltd.?
Letitia Robinson and Rajiv R. Srivastava are named on this Form 483, for the inspection of Aug 26 – Sep 3, 2019. Each investigator has a profile showing what they cite most.
When was Yash Pharma Laboratories Pvt Ltd. inspected by FDA?
The inspection ran Aug 26 – Sep 3, 2019, and the Form 483 is dated September 3, 2019.
How do I get the full Form 483 for Yash Pharma Laboratories Pvt Ltd.?
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.