Ferring Production Inc.
Form 483 issued May 12, 2022 · Parsippany, New Jersey
- Inspection
- Mar 28 – May 12, 2022
- Investigator
- Daniel J. Min
- Observations
- 5
- Pages
- 6
- FEI number
- 3011163401
In short: On May 12, 2022, FDA issued a Form 483 with 5 observations to Ferring Production Inc. in Parsippany, New Jersey (FEI 3011163401) after an inspection that ran Mar 28 – May 12, 2022. The investigator was Daniel J. Min. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Daniel J. Min
8 documents · 2021–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmFerring Production Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ferring Production Inc.?
FDA listed 5 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Ferring Production Inc.?
Daniel J. Min is named on this Form 483, for the inspection of Mar 28 – May 12, 2022. Each investigator has a profile showing what they cite most.
When was Ferring Production Inc. inspected by FDA?
The inspection ran Mar 28 – May 12, 2022, and the Form 483 is dated May 12, 2022.
How do I get the full Form 483 for Ferring Production 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.