Skip to main content
In a recently posted warning letter, a drug manufacturer was cited for receipt and delivery of adulterated drugs. As cited in the warning letter:
We note that an inspection of records at your facility and a review of FDA import data demonstrated that FDA has, in the past, taken regulatory action against at least 23 of your other API suppliers [bold added] for the manufacture of adulterated drugs under section 501 of the FD&C Act by either listing their drugs on import alert and/or issuing them warning letters. Drugs from multiple API suppliers used by PCCA were listed on an import alert, including IA 66-40 for the supplier’s failure to conform to CGMP within the meaning of section 501(a)(2)(B) and Import Alert 99-32 (IA 99-32) for the supplier’s conduct in delaying, denying, or limiting FDA inspections of foreign facilities or providing reasonable access to FDA’s inspectional personnel.
Considering that FDA has found a pattern of drug manufacturers with serious CGMP or other adulteration violations in your supply chain, in response to this letter, also provide a detailed plan to ensure you do not receive or deliver adulterated drugs in interstate commerce, in violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c). Items in your plan should include a full evaluation of your supplier program, including a plan to audit your suppliers. Furthermore, you should also include a full reconciliation of any drugs from the manufacturers listed above, as well as for all firms or drugs currently on FDA import alerts, to determine if you have any remaining drugs in your possession.
Glycerin – this firm repackages glycerin USP and distributes this drug to customers including pharmacy compounders. While the firm does an identify test on each lot, as identified by FDA the testing was incomplete and therefore was not adequate to assure that your glycerin conformed to the compendial standards of identity.
As stated in the warning letter: FDA has received reports about fatal DEG poisoning of consumers who ingested medicinal syrups, such as cough syrup or acetaminophen syrup, that were manufactured with DEG-contaminated glycerin. Historical DEG-related poisonings and fatalities stemmed from multiple violative practices in the glycerin supply chain, including manufacturers not conducting full and adequate identity testing; manufacturers relying on COAs; and COAs, such as those you provide with your glycerin and other drugs, not providing the name of the true manufacturer and thus masking the chain of custody of an adulterated product.
Labeling/ misbranding – as identified in the warning letter, the labels your firm affixed to the following repackaged/relabeled API identify PCCA, but do not designate your firm’s role. Under section 502(a) of the FD&C Act, a drug is misbranded if its label is “false or misleading in any particular.” Further, 21 CFR 201.1(h)(2) specifies that “The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the [FD&C] act, if the person is not the manufacturer of the product in accordance with this section.”
Conclusion: The manufacturer is responsible for the supply chain of their products and should be aware if any of their suppliers are subject to an import alert/ban. This includes performing USP testing to demonstrate identify and purity requirements. Lastly, the label affixed to the drug/api should reflect all manufactures and describe their role.
