Hetero Labs Limited Unit V FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

2. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

In response to this letter, provide a list and summary explanation for all other instances in which product(s) distributed within the last five years failed to meet established specifications, but for which you failed to take actions prescribed by your Quality System Manual and recall procedure. Provide your planned corrective actions and preventive actions (CAPA) for each such instance and explain your CAPA for ensuring that you follow your own procedures regarding product quality and recalls.

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 in all your facilities.

Potential Health Risks

This warning letter summarizes significant violations of current good manufacturing practice (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, Hetero Labs Limited, Unit V at Polepally Village, Jadcherla Mandal, Mahaboob Nag, Telangana, from December 7–16, 2016.

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).

During our inspection, our investigators observed specific violations including, but not limited to, the following.