Is C. O. Truxton Inc. Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.

Unresolved violations in this warning letter may also prevent other federal agencies from awarding contracts.

After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Potential Health Risks

This warning letter summarizes significant violations of current good manufacturing practices (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, atdrugshortages@fda.hhs.gov,so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.

Regulatory Context

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, C.O. Truxton, Inc. (“Truxton”), at 136 Harding Avenue, Bellmawr, New Jersey (FEI 2220338), from April 17 to June 1, 2017.

Because your methods, facilities or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

In addition, your firm mislabeled drug products, causing them to be misbranded under section 502(b)(2) and 502 (e)(1)(A)(ii) of the FD&C Act, 21 U.S.C. 352(b)(2) and 21 U.S.C. 352(e)(1)(A)(ii). By introducing adulterated and misbranded drugs into interstate commerce you are in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).