Watson Pharma Private Limited
Form 483 issued May 20, 2025 · Verna, India
- Inspection
- May 12 – May 20, 2025
- Investigator
- Lauren N. Howard
- Observations
- 3
- Pages
- 5
- FEI number
- 3005719315
In short: On May 20, 2025, FDA issued a Form 483 with 3 observations to Watson Pharma Private Limited in Verna, Goa (FEI 3005719315) after an inspection that ran May 12 – May 20, 2025. The investigator was Lauren N. Howard. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Lauren N. Howard
14 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Ohio.
The firmWatson Pharma 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 Watson Pharma Private Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Watson Pharma Private Limited?
Lauren N. Howard is named on this Form 483, for the inspection of May 12 – May 20, 2025. Each investigator has a profile showing what they cite most.
When was Watson Pharma Private Limited inspected by FDA?
The inspection ran May 12 – May 20, 2025, and the Form 483 is dated May 20, 2025.
How do I get the full Form 483 for Watson Pharma 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.