Search for: "In Re FD Processing"
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20 Sep 2016, 10:00 pm
When FDA re-inspected and re-sampled the SM Fish facility — Aug. 15 to Sept. 9 — testing results showed that Listeria was detected in 12 out of 116 locations, including on a direct food contact surface. [read post]
10 May 2011, 3:24 pm
In anticipation, manufacturers should consider now how they can change manufacturing processes to address the undeclared allergen issue. [read post]
13 Jul 2020, 5:00 am
Although they are listed in the U.S., they’re subject to a "much relaxed" corporate governance and disclosure regime because they're not subject to important rules like Reg FD or releasing ownership reports or quarterly audit reports. [read post]
3 Mar 2020, 9:01 pm
The violations noted by the FDA: “You did not develop an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L. [read post]
27 Mar 2007, 8:57 am
., along with Representatives Emerson, and Pallone and Senators Schumer and Clinton, have re-introduced H.R. 1038, the “Access to Life-Saving Medicine Act,” which would establish a process through which the FDA will be able to approve generic biologics or biopharmaceuticals. [read post]
22 Sep 2019, 9:01 pm
“During the inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. [read post]
6 Oct 2020, 3:03 am
The topics include: – SEC Engages in a Flurry of Rulemaking – Regulation FD Turns 20: Our Take – Something to Look Forward to in 2021: Less Non-Issuer Financial Information – Lynn Jokela [read post]
12 Oct 2018, 10:26 am
In re Elysium Health-Chromadex Litig., 2018 WL 4907590, No. 17 Civ. 7394 (CM) (S.D.N.Y. [read post]
9 Apr 2015, 6:30 am
An operation is like a re-injury and it resets the biological clock. [read post]
21 Feb 2024, 6:10 pm
In the proposed rule, FDA had proposed requiring manufacturers to “obtain the signature for each individual who approved or re-approved the record” (proposed § 820.35). [read post]
14 Nov 2013, 7:41 am
Ct. 2567 (2011), so we’re not going over that again. [read post]
30 Jul 2013, 2:01 pm
July 29, 2013)andIn re Reglan Metoclopramide Litigation, 2013 Pa. [read post]
17 Jan 2012, 9:38 pm
On its website, Ameritox refers to its "Rx Guardian (SM) process. [read post]
15 Nov 2020, 9:01 pm
They further stated that they “understand we need to document all actions taken in our re‐evaluation process” but they have failed to provide FDA with written documentation of any action they have taken (such as a recent audit report that includes a review of their foreign supplier’s environmental monitoring program and their documented review and assessment of that report). [read post]
27 Jun 2021, 9:01 pm
” Further, their hazard analysis identified allergens as a chemical hazard with justification stated as the product is processed in a facility that also processes peanut, egg, fish, tree nut, wheat, milk, and soybean. [read post]
13 Jun 2014, 5:00 am
Even widespread acceptance of an unapproved use in the medical community is no guarantee that the drug is safe or effective for that use, and is no substitute for the rigorous clinical trials, FDA-approved labeling, and careful scrutiny by FDA that the drug approval process requires.FDA Response at 5-6. [read post]
8 May 2023, 9:14 pm
Re–training practices: The MP should state whether the model will need to be re-trained. [read post]
15 Dec 2019, 9:01 pm
., swabs) from various areas in your processing facility. [read post]
12 Nov 2023, 9:01 pm
FDA notes that these serovars are not explicitly addressed in the shell egg regulation; however, they are human pathogens that can cause food to be adulterated under the FD&C Act. [read post]
12 Aug 2022, 4:24 am
To be clear, even in the absence of living stem cells, amniotic fluid and membrane products may still be helpful in the cell regenerative process. [read post]
