Piramal Pharma Solutions Inc.
Form 483 issued January 10, 2023 · Lexington, Kentucky
- Inspection
- Dec 27, 2022 – Jan 10, 2023
- Observations
- 6
- Pages
- 5
- FEI number
- 3006419237
In short: On January 10, 2023, FDA issued a Form 483 with 6 observations to Piramal Pharma Solutions Inc. in Lexington, Kentucky (FEI 3006419237) after an inspection that ran Dec 27, 2022 – Jan 10, 2023. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Deviations from written specifications, test procedures and laboratory mechanisms are…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Laboratory records do not include the initials or signature of the person…
This inspection in context
Questions about this 483
What did FDA find at Piramal Pharma Solutions Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
When was Piramal Pharma Solutions Inc. inspected by FDA?
The inspection ran Dec 27, 2022 – Jan 10, 2023, and the Form 483 is dated January 10, 2023.
How do I get the full Form 483 for Piramal Pharma Solutions Inc.?
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.