Piramal Pharma Solutions Inc.
Form 483 issued February 23, 2024 · Lexington, Kentucky
- Observations
- 2
- Pages
- 2
- FEI number
- 3006419237
In short: On February 23, 2024, FDA issued a Form 483 with 2 observations to Piramal Pharma Solutions Inc. in Lexington, Kentucky (FEI 3006419237). Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Determinations of conformance to appropriate written specifications for acceptance are…
This inspection in context
Questions about this 483
What did FDA find at Piramal Pharma Solutions Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Piramal Pharma Solutions Inc. inspected by FDA?
This Form 483 is dated February 23, 2024.
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.