GF Health Products, Inc.
Form 483 issued November 14, 2019 · Warwick, Rhode Island
- Inspection
- Nov 6 – Nov 14, 2019
- Investigator
- Jonathan G. Matrisciano
- Observations
- 5
- Pages
- 3
- FEI number
- 1218367
In short: On November 14, 2019, FDA issued a Form 483 with 5 observations to GF Health Products, Inc. in Warwick, Rhode Island (FEI 1218367) after an inspection that ran Nov 6 – Nov 14, 2019. The investigator was Jonathan G. Matrisciano. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include a record of all calculations performed in…
- 02
Established laboratory control mechanisms are not followed and documented at…
- 03
The batch production and control records are deficient in that they do not include identification of…
- 04
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
This inspection in context
Jonathan G. Matrisciano
29 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmGF Health Products, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194(a)(5)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GF Health Products, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected GF Health Products, Inc.?
Jonathan G. Matrisciano is named on this Form 483, for the inspection of Nov 6 – Nov 14, 2019. Each investigator has a profile showing what they cite most.
When was GF Health Products, Inc. inspected by FDA?
The inspection ran Nov 6 – Nov 14, 2019, and the Form 483 is dated November 14, 2019.
How do I get the full Form 483 for GF Health Products, 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.