# FDA WARNING_LETTER - Hetero Labs Limited Unit V - December 16, 2016

Source: https://www.keypedia.com/records/warning_letter/hetero-labs-limited-unit-v/137ac1a2-0424-451c-a0ef-c758b2e332b9

> FDA WARNING_LETTER for Hetero Labs Limited Unit V on December 16, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hetero Labs Limited Unit V
- Inspection Date: 2016-12-16
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Hetero Labs Limited, Unit V, following an inspection from December 7-16, 2016, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include:
1.  **Insufficient Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate unexplained discrepancies or OOS results. For example, a customer complaint regarding dissolution failure for (b)(4) mg (b)(4) tablets (lot (b)(4)) was inadequately investigated, with inconsistent conclusions and a failure to identify the root cause or scope of the issue. The FDA requires updated dissolution testing, a retrospective review of all investigations and manufacturing process validations for U.S.-bound products, and a plan for future thorough investigations.
2.  **Equipment Cleaning and Maintenance (21 CFR 211.67(a)):** Investigators observed "clean" equipment with colored residue and in poor condition, such as (b)(4) PDE-2095 having white residue and a damaged gasket. The firm's explanation was deemed insufficient. The FDA demands sampling procedures and analytical methods for residues, procedures for gasket installation/maintenance, an assessment of similar gaskets, and an overall assessment of the cleaning program, including cleaning validation studies.
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## Related Officers

- [Thomas J. Cosgrove](https://www.keypedia.com/people/thomas-j-cosgrove/616abec3-5ed9-42aa-9f5d-392b5552b695)

Company: https://www.keypedia.com/companies/hetero-labs-limited-unit-v/9bc45a12-40e3-400c-81e8-c04a25298d02

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c