Felix Generics Private Limited
Form 483 issued August 27, 2024 · Pithampur, India
- Inspection
- Aug 21 – Aug 27, 2024
- Observations
- 5
- Pages
- 6
- FEI number
- 3014281041
In short: On August 27, 2024, FDA issued a Form 483 with 5 observations to Felix Generics Private Limited in Pithampur, Madhya Pradesh (FEI 3014281041) after an inspection that ran Aug 21 – Aug 27, 2024. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 02
EUPLOVEE,S) SGAATURE DATENSSUED Sterile) Your firm failed to establish written procedures for production and process controls…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Questions about this 483
What did FDA find at Felix Generics Private Limited?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
When was Felix Generics Private Limited inspected by FDA?
The inspection ran Aug 21 – Aug 27, 2024, and the Form 483 is dated August 27, 2024.
How do I get the full Form 483 for Felix Generics 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.