<span class="archive__title-prefix>Posts Categorized:</span> Enforcement

After three weeks of no warning letters, this week the FDA posted five drug GMP warning letters and three device GMP warning letters. We cover them all below. In addition, enforcement actions for failure to comply with the Foreign [Food] Supplier Program are in full swing. Another two warning letters were posted this week, totaling […]

Firms that thought it wasn’t necessary to monitor import alerts that may have been placed against their suppliers received another lesson from FDA in January that they are wrong.  This is not the first warning letter of this type—five other warning letters address the topic including ones issued in 2019 to: Greenbrier International Vipor Chemicals […]

We don’t generally cover warning letters issued for distribution of unapproved new drugs but the one to GOJO Industries Inc., identifies a product that everyone should be familiar with, PURELL® Hand Sanitizer. The defining sentence in the warning letter is, “Your labeling claims that PURELL® Healthcare Advanced Hand Sanitizers are effective in preventing disease or […]

It was a busy week on the warning letter front with one warning letter issued to an HCT/P firm and three issued to OTC manufacturers located outside the US.Along with these warning letters which we cover below, the Center for Tobacco Products cited Smart Toothpicks, LLC in Tempe, AZ, for sale of dissolvable nicotine infused […]

FDA published a variety of warning letters this week including from the Center for Tobacco Products and two more regarding the Foreign [Food] Supplier Verification Program and failure to comply with those requirements (we covered one of the earlier FSVP warning letters here). FDA also posted four GMP drug warning letters, all to firms outside […]

This week we cover three warning letters: two to pharma firms and one to a clinical investigator. DRUG | Health Pharma USA LLC Health Pharma USA LLC (Rahway, NJ) received a warning letter on Dec 18, 2019 based on the outcome of an inspection ending June 3, 2019. The FDA reminds them that as a […]

DRUG | Apollo Health And Beauty Care Apollo Health And Beauty Care (Ontario, Canada) received a warning letter from CDER on December 23, 2019, based on the outcome of an inspection ending August 16, 2019.The firm is a contract manufacturer for OTC drug products.FDA recommends that the firm hire a qualified consultant to assist them […]

This week, FDA posted three drug warning letters, one of which was issued regarding combination products. Again, for these warning letters note FDA’s request for “independent” assessments, continuing the pattern they started a while ago. We also cover a warning letter to a bakery that failed to comply with the [Food] Foreign Supplier Verification Program. […]

Lots of enforcement this week.  FDA published five GMP drug warning letters and one to a device maker. Note that frequently for the information that FDA requests from the firms below, they want an “independent” assessment indicating that they do not think the firm itself is capable or has enough knowledge to perform this activity […]

Enforcement this week included two drug GMP warning letters, both to firms in the US.  In the week prior, FDA posted and then removed a warning letter to a device manufacture that also functioned as a contract sterilizing service.  The letter has yet to be posted again. DRUGS | Ohm Pharmaceuticals Ohm Pharmaceuticals (Mineral Wells, […]