DR. REDDY'S LABORATORIES NEW YORK, LLC
Form 483 issued March 3, 2021 · Middleburgh, New York
- Inspection
- Feb 22 – Mar 3, 2021
- Investigator
- Sony Mathews
- Observations
- 3
- Pages
- 3
- FEI number
- 3006153996
In short: On March 3, 2021, FDA issued a Form 483 with 3 observations to DR. REDDY'S LABORATORIES NEW YORK, LLC in Middleburgh, New York (FEI 3006153996) after an inspection that ran Feb 22 – Mar 3, 2021. The investigator was Sony Mathews. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures for.cleaning and maintenance fail to include description in suffieient detail of methods, equipment and…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
The batch records do not record the distinctive identification number and name of equipment to identify…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmDR. REDDY'S LABORATORIES NEW YORK, LLC history
The site's inspection history, in date order.
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 DR. REDDY'S LABORATORIES NEW YORK, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. 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 DR. REDDY'S LABORATORIES NEW YORK, LLC?
Sony Mathews is named on this Form 483, for the inspection of Feb 22 – Mar 3, 2021. Each investigator has a profile showing what they cite most.
When was DR. REDDY'S LABORATORIES NEW YORK, LLC inspected by FDA?
The inspection ran Feb 22 – Mar 3, 2021, and the Form 483 is dated March 3, 2021.
How do I get the full Form 483 for DR. REDDY'S LABORATORIES NEW YORK, LLC?
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.