Granulation Technology, Inc.
Form 483 issued March 2, 2023 · FAIRFIELD, New Jersey
- Inspection
- Feb 13 – Mar 2, 2023
- Investigator
- Simone E. Pitts
- Observations
- 8
- Pages
- 12
- FEI number
- 3001236066
In short: On March 2, 2023, FDA issued a Form 483 with 8 observations to Granulation Technology, Inc. in FAIRFIELD, New Jersey (FEI 3001236066) after an inspection that ran Feb 13 – Mar 2, 2023. The investigator was Simone E. Pitts. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and facilities & equipment account for 6 of 8 observations.
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 and the failure of a batch…
- 02
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity…
- 03
Complaint records are deficient in that they do not include the findings of the…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Simone E. Pitts
18 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Illinois.
The firmGranulation Technology, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Granulation Technology, Inc.?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Granulation Technology, Inc.?
Simone E. Pitts is named on this Form 483, for the inspection of Feb 13 – Mar 2, 2023. Each investigator has a profile showing what they cite most.
When was Granulation Technology, Inc. inspected by FDA?
The inspection ran Feb 13 – Mar 2, 2023, and the Form 483 is dated March 2, 2023.
How do I get the full Form 483 for Granulation Technology, 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.