Shreepati Pharmaceuticals Private Limited
Form 483 issued December 2, 2023 · Dhar, India
- Inspection
- Nov 28 – Dec 2, 2023
- Investigator
- Rose Jean-Mary
- Observations
- 4
- Pages
- 3
- FEI number
- 3005515162
In short: On December 2, 2023, FDA issued a Form 483 with 4 observations to Shreepati Pharmaceuticals Private Limited in Dhar, Madhya Pradesh (FEI 3005515162) after an inspection that ran Nov 28 – Dec 2, 2023. The investigator was Rose Jean-Mary. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 3 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to ensure that equipment surfaces in contact with raw materials, intermediates do not alter the…
- 02
Failure of your quality unit to ensure that there is stability data to support expiry dates…
- 03
Reserve samples and records associated with the intermediate components, labeling, production, testing control, and distribution, were…
- 04
Failure to demonstrate that (b) (4) used in the manufacture of your intermediates is suitable…
This inspection in context
Rose Jean-Mary
15 documents · 2019–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmShreepati Pharmaceuticals Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.65
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shreepati Pharmaceuticals Private Limited?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Shreepati Pharmaceuticals Private Limited?
Rose Jean-Mary is named on this Form 483, for the inspection of Nov 28 – Dec 2, 2023. Each investigator has a profile showing what they cite most.
When was Shreepati Pharmaceuticals Private Limited inspected by FDA?
The inspection ran Nov 28 – Dec 2, 2023, and the Form 483 is dated December 2, 2023.
How do I get the full Form 483 for Shreepati Pharmaceuticals 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.